HealthBlawg

Social Media Policy Adopted by the American Medical Association

Earlier this month, the AMA announced that it has adopted a social media policy at its mid-year meeting. It will soon be posted on the AMA website; the full text, provided to HealthBlawg by AMA staff, is set forth at the end of this post.

The key to understanding the AMA perspective lies in the title of the policy: Professionalism in the use of social media. The front matter recognizes the utility of social media and focuses on the key issue of concern for the Association: Social media "create new challenges to the patient-physician relationship."

Most elements of the policy are commonsensical, and represent the extension of existing norms into the social media space:

Don't post identifiable patient information online.

Safeguard physician personal privacy online, understanding that anything posted may remain online indefinitely.

Consider separating personal and professional profiles on line.

"What happens in Vegas doesn't stay in Vegas," or, Don't post material that may reflect poorly on the profession.

At least one portion of the policy, though, could potentially impose significant obligations on individual physicians active in social media:

When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions.  If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.

While physicians may have an obligation to monitor and potentially report misbehavior of professional colleagues in other contexts, the notion that individual physicians should be the AMA's policemen across the internet is somewhat troubling, and may have a chilling effect on adoption of social media tools by physicians.

Here is the full text of the policy:

AMA POLICY: PROFESSIONALISM IN THE USE OF SOCIAL MEDIA

The Internet has created the ability for medical students and physicians to communicate and share information quickly and to reach millions of people easily.

Participating in social networking and other similar Internet opportunities can support physicians’ personal expression, enable individual physicians to have a professional presence online, foster collegiality and camaraderie within the profession, provide opportunity to widely disseminate public health messages and other health communication.

Social networks, blogs, and other forms of communication online also create new challenges to the patient-physician relationship.

Physicians should weigh a number of considerations when maintaining a presence online:

(a)    Physicians should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online, and must refrain from posting identifiable patient information online.

(b)   When using the Internet for social networking, physicians should use privacy settings to safeguard personal information and content to the extent possible, but should realize that privacy settings are not absolute and that once on the Internet, content is likely there permanently.  Thus, physicians should routinely monitor their own Internet presence to ensure that the personal and professional information on their own sites and, to the extent possible, content posted about them by others, is accurate and appropriate.

(c)    If they interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just, as they would in any other context.

(d)   To maintain appropriate professional boundaries physicians should consider separating personal and professional content online.

(e)    When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions.  If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.

(f)     Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Update 11/10/2010: Link to AMA social media policy on AMA website provided.

Connected Health Symposium 2010

I attended the Connected Health Symposium last week in Boston. I enjoyed many of the sessions (sometimes wished I could have attended two simultaneously, though the livetweeting helped on that front), and as usual enjoyed the hallway and exhibit floor conversations too.  As is often the case at conferences these days, I had the opportunity to meet several on-line connections in real life for the first time. 

(I will not attempt to give a comprehensive report of the symposium here; please see the livetweeting archive linked to above and other reports to get a sense of the rest of the event.)

This year's exhibit floor included a diverse mix of distance health tools.  Most striking from my perspective was the fact that most of these tools do one of two things: Enable patient-clinician videoconferencing, or upload data from in-home monitoring devices.  The best of the second category also trigger alerts resulting in emails or PHR/EHR alerts to clinicians if vital signs are out of whack, or phone calls to consumers or their caregivers if, for example, meds aren't taken on time (one company had a pill bottle with a transmitter in the cap that signals when it's opened; another had a Pyxis-like auto-dispenser, that looked like you'd need an engineer -- or a teenager -- to program it).  One tool -- Intel's -- seemed to combine most of these functions, and more, into one platform, but it's barely in beta, with only about 1,000 units out in the real world.

The speakers this year seemed to return again and again to several major themes: (1) Is any particular connected health solution scalable? (2) Who will pay for connected health, or mobile health (mHealth)? and (3) Does it work?

These issues are, of course, interconnected.  With the current ACO (Accountable Care Organization) feeding frenzy, and expectations of health reform's full implementation as background, there was a palpable sense, or hope, that all this health-tech-geeky goodness will be snapped up by the ultimate payors for health care. 

Who the ultimate payors are depends on your vision of the future.  Is it health care providers, who will be squeezed by bundled payment demos and mainstream Medicare payment changes coming down the pike under the Affordable Care Act?  Providers have an incentive to save more money than they'll be losing through payment reform under the ACA (and perhaps even the implementation of the SGR [link is to a post on the subject from over a year ago; Congress still hasn't faced the music]-- the latest "doc fix" is slated to expire after the election and fall in the laps of the lame duck Congress).  Is it health care insurers, who are being squeezed by state regulators?  Consider, for example, the recent Massachusetts experience with the Connector -- the model for state insurance exchanges -- and the governor insisting on limited rate increases, with the dispute ending up in court.  Is it premium-paying or self-insured employers?  Is it consumers, or patients?

In addition, the future of ACOs and the rest of health reform implementation is a little unssettled, to say the least.  The law has been thrown to the courts in a series of constitutional challenges, and will be thrown to a new Congress in January.  So even if an investment in some of these systems could eliminate a significant chunk of a physician practice's overhead expense, who's going to invest those up-front dollars right now?

Some of the pricey hi-tech solutions raise my perennial question as well: How many childhood vaccines could we buy with that money?  Roni Zeiger of Google Health tweeted a similar comment attributed to Bill Gates during a presentation on genome sequencing: "I'll get my genome sequenced after we cure the top 20 infectious diseases."

In short, there is recognition that some connected health tools can have a positive impact on health status of individuals and populations, but the key questions center on the cost-effectiveness of those interventions.

One speaker, B.J. Fogg, of the Standford Persuasive Technology Lab, said: "Many crummy trials beat deep thinking," encouraging folks to continue to throw stuff against the wall and see what sticks.  I would take issue with this approach.  For example, the home monitoring devices I described above only upload data to their own proprietary software.  Only one vendor (Intel) seemed to be close to designing an interoperable interface to standard PHRs.  It seems to me that this is a key feature of any such system, and the sooner the vendors adopt this thinking, the sooner they will be able to demonstrate the utility of their products and grow their markets.

On the "Does it work?" front, many speakers addressed the issue of behavior change.  All of the tools discussed at the symposium are, in essence, intended to make change in personal behaviors easier to accomplish.  While much of the behavior change discussion was laced with paternalism, it had, at its core, a remarkable patient-centered orientation.  This orientation was emphasized by a discussion on process and outcome measures of the future, to be used as a means for calculating incentive payments to health care providers.  One speaker insisted that the most useful measures will be patient-centric measures: patient satisfaction, patient compliance, etc.  The difficulty lies in reaching the point where patient and consumer behavior is being changed appropriately. 

This raises the question: How do we reach consumers?  What incentives will people resond to?  What options do we need to present to individuals, and how?

Sheena Iyengar delivered a terrific keynote on choice, making the point that in our society we have too many choices -- about everything: breakfast cereal to jam to mutual funds in our retirement plans to Medicare Part D plans.  Research shows that the optimal number of choices to lay out before human beings is 7+2, and that more choice results in no choice at all being made -- no mutual funds selected for retirement, no Medicare drug supplement plan selected to help with prescription medication costs.

Kevin Volpp, from the UPenn Leonard Davis Institute Center for Health Incentives, spoke about how we do, and can, incentivize healthy behaviors, noting that many accepted approaches are shown through research to be ineffective -- e.g., posting calorie counts on menus, CDHPs, reducing copays.  One interesting positive note: lotteries can improve compliance with healthy behaviors in a cost-effective manner.  Volpp gave a compelling example of a medication compliance study that increased compliance by giving compliant patients the chance to win money in a lottery if they took their meds.

Overall, there was consensus that the reason we don't have all the latest tech available in service of health care is that the economic model for health care in this country is broken, thanks to skewed incentives based on the fee for service model.

To me that seems to be too facile an excuse, explaining only the failure of health care providers to adopt these tools on their own initiative.  Gary Gottlieb, CEO of Partners Healthcare addressed one plenary session and emphasized that the work of the folks in the room was critical to the success of Partners -- precisely because of the cost-saving potential of the solutions at various stages of development.  This is of critical importance to Partners as it seeks to prepare for success as an ACO and, more broadly, for success in a market less willing to see things its way than in the past.

Ultimate payors have always had the incnetive to improve health care processes and outcomes, and they are getting more and more sophisticated about it.  ACO's may be the latest (provider-centric) frame for the discussion, but the (ultimate payor-centric) patient-centered medical home frame has been around for a while, and may even prove to be a key engine for ACO success.

Back to patients. The key to success in transforming health care in this country is patient engagement, so patient-centered care, delivery of information to patients, and the enabling of patient community are the goals that health care providers and their connected health vendors need to focus on.

The concluding presentation from Joe Kvedar demonstrated that patients are more likely than we may expect to prefer interacting with computers vs. people in certain circumstances.  As symposium participants struggled with the challenge of scaling their solutions, this insight provided some comfort.  In an earlier session, Adam Bosworth described his goal for Keas as broader than scaling an individual solution.  He hopes to have his company's service act as a platform for other developers' applications -- creating an ecosystem for health apps benefiting individuals and underwritten by the ultimate payors for health care (in Keas' case, employers).

Scaling, payment, utility -- several of the challenges lined up opposite the connected health community.

All in all, this year's Connected Health Symposium showed that the potential exists for (lower case) meaningful use of a whole heck of a lot of tools and toys.  The challenge is to execute on this potential.   

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

OIG: Imaging pre-authorization may be handled by hospital for referring docs and patients

The OIG released an advisory opinion at the end of last month OK'ing a hospital's proposal to provide insurance pre-authorization srevices free of charge to patients and physicians.  This is an issue that has long vexed folks in the imaging world.  Clearly, this is a free service provided to referral sources (to the extent they are obligated by contract with third party payors to obtain the pre-authorization before referring a patient for an MRI, for example), so why is the OIG OK with it?  In the opinion, the OIG blesses the arrangement for four reasons:

• The arrangement doesn't target specific referring docs, so the pre-authorization service will be provided for patients of docs who are contractually bound to handle it themselves, as well as for patients of those who aren't, and thus the risk of using the arrangement to reward referrals is low
• The hospital will not pay the docs under the arrangement and will not guarantee to docs that the pre-authorizations will be forthcoming (the OIG also notes -- not sure why -- that the hospital will collect and pass on only such personal health information as may be necessary to secure a finding of medical necessity for the pre-authorization) 
• The hospital staff will be transparent with payors and referring docs, and will have little influence on steering volume, because they get involved only after the hospital has been selected (other situations are distinguished, e.g., where referral seekers provide referral sources with staff like discharge planners)
  
• The hospital has an interest in being paid for its services, and thus in ensuring that the pre-authorization process is conducted properly, thus "lower[ing] the risk that the ... [a]rrangement is a stalking horse for illicit payments to [the hospital's] referral sources"

Well, the reasoning here doesn't really cut it, as far as I'm concerned.  Referring docs and their staffs hate having to deal with the pre-authorization process, and if a hospital takes on that headache, that's a real benefit (remuneration, in the language of the anti-kickback statute).  If there are two hospitals in town, and -- all other things being equal -- one provides pre-authorization services and the other doesn't, guess where all the docs will refer their patients?  It doesn't really matter that the service is provided to all docs, for all payors.  It is still clearly an inducement.  If, on the other hand, all hospitals take on this added cost of doing business, then nobody gains a competitive advantage.  Finally, to the extent physician networks are more and more tightly tied to particular hospital systems (whether through employment or other relationships, post health reform), the potential for steering volume is negligible at best.

Bottom line: I agree with the outcome, but not the reasoning.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Privacy and security of patient records: The lesson of the weakest link

The Queen of Soul famously wailed about being a link in a chain of fools.  Today's lead story in the Boston Globe tells us about another sort of link in the chain -- the weakest link in the chain of custody of patient records.  In brief, a pathology billing service bought out by another service apparently dumped all records more that a year old in a town dump; a Globe photographer taking out his own trash noticed that the paper records (which he was looking at because he thought they ought to be recycled rather than dumped) had identifiable patient data and represented at least four hospitals from across Eastern Massachusetts.  Clearly, these records ought to have been shredded or otherwise destroyed before disposal.  Assuming they had some airtight contracts in place, the hospitals involved may well be looking to the seller of the billing service in this case to reimburse them for costs of:

• identifying the patients involved in this data breach
• notifying affected patients of the breach
  
• providing credit monitoring services to affected patients
• any damages incurred by patients
• any fines incurred by the hospitals

Under the HITECH Act's "Son of HIPAA" rules, the hospitals could be on the hook to the federales for up to $1.5 million in fines each as a result of this incident, and the state AG could get in on the action as well, filing suit on behalf of the affected Massachusetts residents and seeking to ensue that proper procedures are in place.  There may also be a violation of the state data security law here as well.  Massachusetts has a particularly stringent data security law on the books that took effect within the past year, and not all affected businesses have come into compliance.  The AG may be on the prowl for a few high-profile cases, like this one, in which to levy substantial fines and convince the laggards that compliance would be more than worth their while.

The natural question to ask, given the facts of this case, is: What Would a Meaningful User Do?

With the ink barely dry on the meaningful use final rule, and the usual suspects lined up for and against the proliferation of EHRs, it seems clear that the use of electronic health records would have eliminated the problem of plain text paper records flapping in the wind at the Georgetown town dump.  However, their use would not have eliminated the problem of covered entity and contractor bad judgment, if that is in fact the issue in this case.

Digitizing records does not eliminate covered entities' responsibilities with respect to the operation of their business associates and subcontractors.  As we all know, the latest and greatest laws and regs make covered entities fully responsible for the deeds and misdeeds of their business associates and subcontractors.  (True even if the breach notification final rule is on ice for a while.)  Thus, it becomes imperative for covered entities to have a much better handle on their associates' understanding of applicable law, on their policies and procedures, and on the actual implementation of their policies and procedures.

Auditing business associate and subcontractor compliance with HIPAA and other privacy laws is probably worth the expense.  The costs saved include being called out on page one, above the fold.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Meaningful Use: The Final Rule

Meaningful use was given its final definition yesterday, in the meaningful use final rule released by HHS.  Secretary Sebelius, CMS Adminsitrator Berwick, ONC chief Blumenthal and the two Reginas spoke -- U.S. Surgeon General Regina Benjamin, and Regina Holliday, whose late husband's last days were complicated by the failure of health care facilities to release and share health records.  Berwick, in his first full day on the job as CMS Adminstrator, waxed rhapsodic about the pleasures of practicing as a pediatrician at Harvard Community Health Plan using its pioneering electronic health record system.  (Years later, I am still a patient at Harvard Vanguard Medical Associates, which used to be part of HCHP, and I am still spoiled by the EHR system there.)  Blumenthal and Benjamin also spoke about how and why they came to use EHRs in their clinical practices, and why they wouldn't have it any other way.  (The rule will be published in the Federal Register July 28.)

Also released was the proposed permanent EHR certification rule.  (Last month, the federales released a temporary version of the EHR certification rule, so that there would be standards in place for providers seeking HITECH Act incentive payments for 2011 meaningful use of certified EHRs.)  Taken together with the draft regulations updating HIPAA privacy, security and enforcement rules under the HITECH Act announced last week, these rules outline the future of health care IT in this country.

Not surprisingly, after receiving over 2,000 comments on the draft definition of meaningful use released over six months ago, the feds revised the rule considerably, loosening the definitions of Stage 1 Objectives (i.e., the criteria by which 2011 compliance and eligibility for the full incentive payments will be judged), among other things.

The HHS fact sheet (available on the relatively new CMS EHR Incentive Programs web page) describes some of the key components of the rule as follows:  

• For Stage 1, CMS’s proposed rule called on physicians and other eligible professionals ("EPs") to meet 25 objectives (23 for hospitals) in reporting their meaningful use of EHRs. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers can choose.  This “two track” approach ensures that the most basic elements of meaningful EHR use will be met by all providers qualifying for incentive payments, while at the same time allowing latitude in other areas to reflect providers’ varying needs and their individual paths to full EHR use.
• In line with recommendations of the Health Information Technology Policy Committee, the final rule includes the objective of providing patient-specific educational resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals.
• With respect to defining hospital-based physicians, the final rule conforms to the Continuing Extension Act of 2010. That law addressed provider concerns about hospital-based providers in ambulatory settings being unable to qualify for incentive payments by defining a hospital-based EP as performing substantially all of his or her services in an inpatient hospital setting or emergency room only.
• The rule makes final a proposed rule definition that would make individual payments to eligible hospitals identified by their individual CMS Certification Number.  The final rule retains the proposed definition of an eligible hospital because that is most consistent with policy precedents in how Medicare has historically applied the statutory definition of a ”subsection (d)” hospital under other hospital payment regulations.
• Under Medicaid, the final rule includes critical access hospitals (CAHs) in the definition of acute care hospital for the purpose of incentive program eligibility.
• The final rule’s economic analysis estimates that incentive payments under Medicare and Medicaid EHR programs for 2011 through 2019 will range from $9.7 billion to $27.4 billion.

Not only did the government go the "Chinese menu" route in allowing providers to customize the standard set that will be applicable to them; it also made the standards much less stringent (e.g. threshhold of 40% e-prescribing vs. 75% in the draft rule; though one must wonder whether this is mere window dressing, as an EP with an e-Rx system in place would not be likely to use it for anything less than 100% of patients).  That's not to say that qualifying for the incentives will be a breeze, though some naysayers are criticizing the feds for that reason.  On the other hand, there are plenty of voices out there decrying the difficulty providers will face in trying to qualify for the full incentive payments in the time remaining.  Finally, there are those who still question the value of this whole exercise, seeing it as a Recovery Act handout for the EHR vendors more than anything else, wondering when and where the clinical benefits will materialize.

The EHR vendors that are guaranteeing compliance with meaningful use are now in overdrive, working on the interim certification for their products, and looking to sign up providers now that the meaningful use rules have been finalized.  Hospitals and EPs that are not already in the midst of implementation may be hard-pressed to achieve meaningful use of a certified EHR before the first deadline in 2011.  Most will be able to pull it off by 2015, when the incentives for EHR adoption switch over to penalties for failure to get wired.  (The cynics among us may see a future legislative deferral of the penalty provisions, just as we have been getting used to regular last-minute deferrals of SGR formula-driven physician reimbursement cuts.)  Some vendors are offering advances against incentive payments, in addition to compliance guarantees (see, e.g., GE's healthymagination program).

The FDA did not insert itself into the final rulemaking process, as some had hoped or expected.  The FDA has asserted jurisdiction over EHRs as "devices" and the regulated community would sure as heck like to know sooner, rather than later, just what the FDA has in mind for regulating EHRs (no pre-market approval, methinks). 

Finally, the criteria established and to be met are not ends in themselves, but a means to a further end: the improvement of quality while reducing cost -- two legs of the proverbial three-legged stool.  (The third leg, access, may be improved through other aspects of the Obama administration's health reform initiatives.)   As the meaningful use rule and the revised HIPAA rules come together in seeking to promote a migration of health data to a near-universal online, interoperable state, some e-patients and patient advocates will measure the success of the implementation by its satisfaction of the Declaration of Health Data Rights.  Let's hope that the deferral of PHR-EHR connection requirements don't sidetrack the patient empowerment side of this rule.

There are many, many other issues dealt with and implicated in the more than 800 pages of the final rule, and many other commentators writing about them.  I invite you to peruse the rule and some of the other materials linked to in this post, and to offer your thoughts on the rule and its implications below.

For further reading:

The Stage 1 Meaningful Use objectives and associated measures, broken out by "core" and "menu" set are found in Table 2, beginning on page 221 of the final rule PDF released yesterday.

A helpful side-by-side comparison of final vs. proposed rule Stage 1 objectives and measures may be found at Keith Boone's blog (together with an analysis of the certification rule).

Another helpful meaningful use summary (courtesy of the federales) is available via the New England Journal of Medicine.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

ONC announces HITECH amendments to HIPAA privacy, security and enforcement rules

The federales announced a new set of HIPAA regulations today (to be published in the Federal Register on July 14) in a press conference featuring Kathleen Sebelius (HHS Secretary), Georgina Verdugo (HHS OCR Director) and David Blumenthal (ONC Director).  The HIPAA changes are essentially mandated by the HITECH Act.  From the HHS presser:

The proposed rule announced today would strengthen and expand enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Enforcement Rules by:

• expanding individuals’ rights to access their information and to restrict certain types of disclosures of protected health information to health plans;
  
• requiring business associates of HIPAA-covered entities to be under most of the same rules as the covered entities;
• setting new limitations on the use and disclosure of protected health information for marketing and fundraising; and
• prohibiting the sale of protected health information without patient authorization.

Two new websites were announced as well.  One is a beefed-up version of the HIPAA data breach notification wall of shame, and the other is a new HHS privacy website directed at the general public, now up at hhs.gov/healthprivacy.  This website, a joint statement from ONC and OCR posted today, and the tenor of the federales' remarks today indicate a deep concern about public perceptions concerning privacy and security of protected health information -- sort of a "what if we throw a party and nobody comes?" vibe.  This was magnified at today's press conference by comments about maintaining individual patient control over the use and dissemination of protected health information -- the proposed rule includes a revised definition of marketing (in the context of using PHI for marketing purposes), and it was interesting to hear how concerns about privacy and marketing were presented (and received, e.g. by the first questioner, patient privacy advocate Deborah Peel).  In addition, the HHS listening session road show will kick into gear on this issue because they "want these policies to have the support of the American people." 

The meaningful use final rule (which Blumenthal said today would be out "very shortly" and will include additional health care provider data security requirements), and all those HITECH Act incentive dollars and, most importantly, all that highly-anticipated, interoperable-HIT-generated, health care improvement goodness, all depend on patient acceptance of the use of EHRs, so the concern for protection of patient privacy and security is well-placed.  It remains to be seen whether the general public is prepared to trust the medical-industrial complex in this way, and whether the medical-industrial complex will be able to either meet the high bar for meaningful use set in the proposed rule, or bend the federales to its will.

Finally, another couple of important nuggets from the NPRM: 

• Business Associates get virtually full Covered Entity treatment in the proposed rule, including exposure to the up-to-$1.5m fines ... and subcontractors of business associates are reached by the long arm of the law, too.
  
• Compliance dates for most of the new rules will be 180 days from publication of this rule as a final rule.  We get a year to put all of our business associate agreements in order.
• A handful of changes not specifically required by the HITECH Act are thrown in -- one example is the inclusion of "reputational harm" in addition to physical or financial harm as potentially aggravating factors in determining the amount of a fine.

I invite all readers to take a look at the NPRM, examine key issues of concern to them, and post observations, comments and questions here -- and at regulations.gov once the comment period opens next week.

Update 7/14/2010:  Here is the official version of the proposed HIPAA rule amendments on privacy, security and enforcement, from today's Federal Register.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

GE Healthcare IT's SVP and General Manager of eHealth Earl Jones speaks with David Harlow about the connected health care ecosystem

GE Healthcare IT has been working in the years leading up to the HITECH Act on a number of initiatives to enable meaningful use of health care IT -- or as Senior VP and General Manager of eHealth Earl Jones puts it, building the "connected health care ecosystem."

In what may be seen as either a pragmatic move or a revolutionary one, GE is developing tools that allow for communication across health care IT systems -- not just connecting one GE Centricity installation with another -- but acting as a technology-agnostic bridge for information across health care IT systems and across health systems.  While Jones notes that we're in the early stages of linking isolated lily pads across the surface of a pond, GE is developing tools that not only facilitate interoperability, but also facilitate the dissemination of medical knowledghe and the use of clinical decision rules developed locally or by pacesetting health systems (e.g., Mayo, Intermountain -- see the discussion of Qualibria below).

The audio file of my interview with Earl Jones (about 35 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked Earl Jones, SVP and GM, eHealth, GE Healthcare IT, HealthBlawg interview transcript).

While he is necessarily politic about the role of regulators in the development of health care IT, Jones is clearly excited about the breadth and depth of GE Healthcare IT's reach, the way in which its priorities dovetail with change management initiatives in US government, and the ways in which it can enable clinical care and population health improvements.  Please join us for a wide-ranging discussion of these issues.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog

Interview of Earl Jones, SVP and GM, eHealth, GE Healthcare IT

April 1, 2010

David Harlow: This is David Harlow at Health Blawg and I have with me today Earl Jones, who is the Senior Vice President and General Manager for eHealth at GE Healthcare IT. Hello Earl, how are you today?

Earl Jones: I am doing just great, thank you.

David Harlow: Well thank you for being with us Earl. I have to ask you, first question as we start off today is - I’d like to ask you to define eHealth. That is the definition of your bailiwick.

Earl Jones: Sure. So eHealth speaks to this concept of the connected health care ecosystem. So I think all of us as professionals in the health care industry, but also as patients in the health care industry deal with really frustrating issues associated with moving clinical information from provider to provider. The classic use cases that we talk about are: mom goes to the hospital with her kids would really love to have medical information from their primary care physician. That information isn’t available to the hospitalist at the time of care treatment. Trying to get information from the hospital back to your primary care physician, those are challenging. That ability to move clinical information around the health care community is -- causes problems at that care level, also causes some, or it precludes us from getting at some real opportunities to improve the health care system like making cross-enterprise workflows faster, easier, cheaper; allowing us to do new care models like managing chronic diseases better, like bringing things like clinical decision support and population health to bear.

So eHealth speaks to this concept of the things that we can do in the connected health care ecosystem. We define eHealth more structurally as, at its core, health information exchange, the ability to take health information exchange and to do things with it. So collaborative workflows and then trying to bring performance application like quality reporting and clinical decision support and make those things available across the enterprise. So that’s what we think about when we think about eHealth.

David Harlow: Okay, great. This division or business unit within GE Healthcare has been formalized within the past 6 to 12 months I believe, maybe slightly more recently.

Earl Jones: Yeah.

David Harlow: Is that a structural change is that a new focus for GE Healthcare or is it a new name for what you’ve been doing previously?

Earl Jones: So I think it might be helpful to put GE Healthcare IT into context. So GE Healthcare as you know we are a big global health care technology provider. GE Healthcare is about an $18 billion business and it does three things primarily. GE Healthcare does diagnostic technology, MRI, CT, PET ultrasound, really focused on core health care technology. GE Healthcare does life sciences, so protein synthesis for example, bio-markers, the whole area of life sciences. And then the third part of GE Healthcare is GE Healthcare IT. And so we’re a multi-billion dollar global healthcare IT provider. And GE Healthcare IT has traditionally done three things; imaging systems, that’s radiological information systems, picture archiving; software for hospitals; and then software for physician practices. This concept of eHealth -- we started it as a new product line last year. But it was really born out of work that we started about 5 years ago, long before health information exchange or eHealth were topical issues like they are today.

We started this issue with a handful of our customers a few years ago who just had this problem of, wow, I wish we could share clinical information within our community and we started working with them around terminology, around hosting services, around translation, de-duplication services, really putting that core infrastructure in place that allows clinical information sharing. So it’s something we’ve been doing for several years. But last year we elected to break this out into its own business unit for a couple of reasons; one is certainly with the stimulus that’s happening here nationally and there is a lot of stimulus and attention on eHealth infrastructure globally. We thought it would be a little easier to talk about ourselves and what we are doing for our customers with our technology.

The second is, and I think it’s an important issue – it’s important to keep in mind, if you really want to enable cross-community clinical information sharing you have to be able to do it in a technology-agnostic way, this can’t be about sharing information amongst GE systems from hospitals to doctors office to specialty facility. It’s got to be able to share – we’ve got to be able to share clinical information in the environment that our customers live in and that environment is heterogeneous software applications, a disconnected variety of terminologies, the continuum along adoption of standards varies dramatically, I mean that’s the technical and systems complexity that our customers live in. And so it’s important for us to break this out into its own product line, really send the message that this isn’t about GE Centricity connectivity; it’s about enabling clinical information sharing in the environment that our customers live in without having to rip or replace any software.

David Harlow: Well that sort information sharing really sounds like the holy grail of Health IT and I am wondering how successful you’ve been or where you see yourself on the trajectory of really implementing that kind of connectivity?

Earl Jones: We feel like this has a transformative potential, this whole movement of connected care has a transformative potential in healthcare. Now let me characterize this by an example; I spent a lot of my early career in supply chain, and I was there when the factory couldn’t talk to the warehouse and you literally would have to write down material pulls on a piece of paper and send a runner off to get material. And in the span of a relatively short amount of time, 15 years, we went from that to a globally connected supply chain. And every metric that you can think of in supply chain got better, profitability, performance, service level, velocity. New business models were created; it was transformative when we connected trading partners in supply chain. And I think that kind of analogy, kind of parallel is exactly -- we’re on the precipice or the beginning phases of seeing that happened in healthcare. And we’ve been working with customers that are doing some very interesting things. One of our customers is The Boston Medical Center and The Boston Medical Center -- it’s an inner-city hospital here in Boston – it’s connected with 13 unaffiliated clinics. So clinics that have a different governance structure from Boston Medical Center.

And they came together and they said wouldn’t it be great if we could share clinical information in our community? And they did that using our health information exchange technology, and they’re doing some really fun things with it, right? They are able to do things like health emergency room doctors make better care decisions. So it’s tough being an ER doc. An ER doc gets the patient, may have no medical history of the patient and often times they are dealing with some pretty acute issues. Now at The Boston Medical Center if a patient comes in, if they are part of the community and belong to one of the community clinics, if there is no medical record at the ER at the Boston Medical Center for the patient, the ER doc can look into the local clinics and via the health information exchange and get information about the patient. And these can be life-saving kinds of information, thing like allergies, medications that the patients are on. Being able to get that kind of clinical information to an ER doc is important.

They are also using the health information exchange to enable a better way of doing referrals management which in healthcare is an awkward and expensive process that often ends with a lot of patient and doctor frustration because it’s not well managed from an information perspective. They are doing population health, right? They’re able to, now, because of sharing clinical information in their community, they’re able to understand the overall impact of some of their patient outreach programs because they can actually see it in the data whether they are making a difference. So, here we are in Boston, small hospital, a relatively small community, doing some really important things in their community because they’re able to share clinical information. That’s kind of exciting.

David Harlow: It is -- and I guess the next step is to see whether this can be bridged beyond a local system where it’s a dozen or so community health centers that are affiliated with Boston Medical Center and take that beyond. So someone who is away from home, out of town, goes into an emergency room can those records be pulled up remotely or is that something that you see us heading toward?

Earl Jones: I think we are squarely in the early adoption phase of this whole eHealth program. I mean we’re in the first steps of the first mile of a marathon. But looking at parallels in other industries, if we stay committed, if we continue to focus on value, in the span of what could also be a relatively short amount of time, it’s not inconceivable that we’ll have the way to share the information nationally for the betterment of care providers and patients. So we’re not there yet, I mean you can think of where we’re heading as lily pads on a pond that we’re going to see a lot of community health exchanges like Boston Medical Center pop up and start filling the pond and the good news is that organizations like IHE have been thinking about how do we make these lily pads, how do we make these community health information exchanges, work together and so there are good protocols and methodologies for cross-community access of information that over time we’ll see get built out.

David Harlow: Are you optimistic about some of the Federal initiatives building on the ARRA and HITECH Act initiatives on local medical records systems, to build out the NHIN Connector or other sorts of interchange infrastructures, through Beacon Communities or other programs?

Earl Jones: I give ONC a lot of credit. This is a thorny problem, a lot of stakeholders, a lot of different ways to come at this, and what they have done is they said look here are some functional requirement of things that we want to try to get accomplished because they are going to make the health care system better. Here’s $42 billion to help get you going, and if you aren’t adopting the technology for the betterment of our national health care system, in a handful of years we’re are going to move from carrot to stick, it’s just conceptually, what they are trying to do from an overall change management perspective makes a ton of sense and it really by any measure what the ONC has done has really crystallized this concept of connected care in our industry.

NHIN is interesting, I think NHIN is evolving; I am not sure what NHIN will look like whether it will be servers moving data or it will be just a concept that we are building toward. I don’t know what it is going to look like in future I am not sure ONC does I think that’s something that’s evolving and I think that’s okay. This concept of Beacon Communities which you brought up I think is brilliant. You know in any large organization change management -- and by any definition trying to change US health care system is a large organization change management problem -- one of the best ways to drive momentum behind the change program is to create showcases. You know, let’s go create some examples of where people are out ahead of the curve in technology options, out ahead of the curve in thinking through new process and ways of using data and bringing communities together. In using those showcases sort of as beacons to bring the rest of the organization along and in context, I thought the Beacon Communities program is brilliant and you know let’s hope that monies that gets flown down to Beacon Communities when the final grants are announced, let’s hope that folks put that money to good use and really create some spectacular showcases that prove the case for why connected health care is so important.

David Harlow: Now we might say that the government gives with one hand and maybe takes away with the other. In concert with the grantmaking and incentive producing rules and regulations that have been coming out, there is also now a discussion about regulation of health care IT as a device by authority of the Food and Drug Administration. I guess some would say that you can’t really serve two masters, and that the Federal government should come up with some sort of integrated approach on eHealth and EHRs and other related systems and programs. The FDA is working with ONC on trying to develop a way to work together, I suppose. I am wondering if you could speak to through your experience with these organizations, these agencies, and where do you see this heading? Where would you expect this to end up? Or where would you like this to end up?

Earl Jones: The FDA often gets tough rap because their job is tough one. They really perform an important public service which is ensuring that things like health care are out there for the betterment of the citizens of the nation and aren’t doing negative things around helping improve people’s health and welfare, so you know they have a tough job, I have tremendous respect for professionals that work in FDA and you know I think they wake up every day really thinking about how they do their job as best as they can do it to protect the citizens in the US. As far as my experience has been they have been very, very reasonable in their approaches. I think they could take some very draconian regulatory positions if all they want to do is think about their job only as regulator. But I have always found them to be very open in thinking about how to work through a problem in a balanced way and as far as I can tell when it comes to health records they are doing that very thing. They haven’t just launched in, saying look, we’re going to go regulate it, they haven’t said that this is off the table either, because they recognize the importance of IT in the overall health care continuum.

So, from my observation is they are taking a very measured approach. All I can say however it comes out you know GE is no stranger to regulated environments we are ready for it; if it doesn’t get regulated, that’s fine to. The only thing that I think we would encourage is -- let’s not slow the progress down that ONC is driving; I think we really do have some great momentum, if it ends up regulated let’s come at it in a way that doesn’t slow the market down. I think that calls for good balance, good collaboration and my sense is that FDA has got that top of mind.

David Harlow: So I think that the FDA may be working together with ONC so that some of these regulations may end up folded into the meaningful use certification process. So to the extent that all can be harmonized, it’ll certainly be better than having to deal with two separate organizations.

You spoke earlier about respecting the patient-centered aspect of health care IT and I am wondering whether you see this sort of regulation as a challenge to that? And also whether -- how you would characterize some of the work that your organization has being doing, in meeting the needs of patients in a patient-centered sort of way.

Earl Jones: Yeah. It’s a great question. I think there is a lot of discussion around moving from a payor/provider-centric to let’s go put the patients in the middle because that’s really at the end of the day what’s this is all about – care, treatment, for the patient. And I think it’s a very healthy dialog. The whole concept of electronic health records, and again let me just be clear electronic medical record -- think of it as sitting on a computer in a doctor’s office, literally or virtually. Electronic health record is a sum aggregation of the health information of the patient that lives within a healthcare community. And this concept of electronic health record, one patient, one record available to the primary and specialty care providers that are treating a patient, that’s a very patient-centric concept which is absolutely what we’re trying to enable with eHealth. Things like privacy and security -- those things we take very seriously and are very integral parts of our health information exchange infrastructure. And -- so I think this whole focus of how do we empower patients more, with better information, better tools and do it in a safe, secure private way is exactly what we are trying to do with our solutions.

David Harlow: Great. Now one of the solutions or products that you’re rolling out is Qualibria, which was previewed or announced at the HIMSS conference a month or so ago. I am wondering if you could explain a little bit what that system is, what it’s built on, and how you see it rolling out?

Earl Jones: Sure. We are exceptionally excited about Qualibria. Qualibria is a clinical knowledge platform. So what does that mean? Let me characterize this by the problem that we were trying to solve with this technology. Dartmouth did a study and said if everybody in the nation was as good at care treatment as the Mayo clinic, they said $40 billion would have come off that number [cost of care] and if everybody was as good as Intermountain something like $119 billion would come off the number. I am probably misquoting the numbers. But the concept is it turns out Mayo and Intermountain are really good at what they do and if we could just harmonize and reduce the variation in care treatment across the country, we could take a substantial chunk of the cost out of the system by just providing better care.  There are couple of other alarming stats that go along with this; one is that the medical body of knowledge is doubling every 8 years, or more quickly. And I think we can go: Wow, when all this genomic stuff starts hitting, we start getting really targeted around that kind of care treatment based on genomic data you can see the medical body of knowledge exploding even at a more accelerated rate. Tie that in with the fact that it may take as much as 17 years for a best practice to propagate out throughout the medical community, you quickly get this vision of, wow, there’s a lot of variation in the quality of care delivered and as it turns out, we patients only get the best practice treatment -- for whatever the disease state or illness or injury that we’re dealing with -- we only get the best practice care treatment a little over half the time, like 55% of the time.

So the problem Qualibria was trying to solve was, wow, can IT do something to make that better? And it turns out it’s really hard. The things that Mayo and Intermountain are doing – they’re instantiated their own systems but they are pretty complicated sort of flow chart processes for treating something like acute respiratory disorder. I mean it can be as detailed as: at this time turn the respirator to this value, give the medication certain minutes after this care treatment.

Trying to take that and do it in a system like Intermountain’s hard. Trying to translate that across systems, turns out you had to rethink the architecture. And that’s what we did with Qualibria. So with this partnership with Intermountain and Mayo we launched into a total rethink of a technology architecture which includes a pretty advanced clinical element model and something like several tens of thousands of rules that are then built on top of the clinical element model that allow you to take complex terminologies, draw insights and attributes from that and use that clinical element model to create decision support tools. And Qualibria is our first product that’s going to roll out from the partnership with Intermountain and it’s designed to do that very thing, which is take disparate information, aggregate it, be able to put single patient, multi-patient views with clear alerts and processes and tracking that can immediately become useful -- I don’t have to rip anything and replace it -- drop it in and immediately become useful in a hospital clinical setting in driving better coordinated care. So it’s very exciting.

David Harlow: You sound excited; sounds like a very exciting project and product. So do you see this rolling out beyond Intermountain and Mayo in the near future?

Earl Jones: Yeah absolutely. I think our product plan is to – so it’s up and running now -- and to roll it out to a couple more controlled sites the balance of this year, before a more broad national rollout in 2011 and will quickly be followed by international rollouts as well. So it’s something that we put a lot of research and development money into, we’ve got great partners that are helping us and I think it’s important to point out that we love Mayo, we love Intermountain -- I mean their bona fides are tremendous. But there are a number of healthcare institutions that are doing some really wonderful things in advancing the medical body of knowledge on specific care protocol treatments. And this technology can allow them to better and more quickly roll out the things that they learn as well. You can build your rules right into the tool. So we’ll have care bundles that are mapped after what Intermountain and Mayo do; it’s also going to be a wonderful environment to quickly take things that hospital systems are doing in an excellent fashion themselves and instantiating that in a tool that can be rolled out across their enterprise.

David Harlow: Now with this new kind of tool, do you have a concern about new kinds of liabilities, legal liabilities, as you are essentially rolling out as you said bundles of decisions support rules -- does that not come along with additional liabilities, whether it’s the content or the application of the rules or even perhaps a different kind of liability interms of encountering corrupted data or other sorts of problems rather than the decisionsupport rules themselves.

Earl Jones: Well I am not the best person to answer that question. Certainly we take all these things tremendously seriously and it’s been very well thought through. None of this replaces the need to have experienced care professionals orchestrating the care delivery, right? This isn’t -- lets get rid of docs and nurses. This is about how do we help docs and nurses deal with the tremendous complexity and a tremendous body of knowledge and time variant change of body of knowledge. It’s about giving them some tools that can help them do their jobs better. So I think that’s a very important distinction that -- I think there is a statement that says something to the effect that the complexity of modern health care surpasses the human mind sort of gets your mind around it. It’s too big for anybody so we think that what we are trying to do is not replace docs and nurses -- quite the opposite – it’s to give them some important tools to help them do their jobs better.

David Harlow: So are these tools part of what the company has been referring to as healthymagination and a large investment and innovation and health care?

Earl Jones: That’s certainly part of healthymagination so let’s talk about healthy. And first I’m going to talk about something different -- I am going to talk about ecomagination. So we launched this program about five years ago called ecomagination and at the time one of the real pressing global issues is the environment; it still is. It’s a huge, huge problem, and Jeff Immelt, to his great credit, stood back and said, you know, as the General Electric Company we can be doing more to help this important issue of environmental sustainability. He said let’s do it like an operating company, like GE ought to do it, which is let’s set ourselves some clear goals, clear metrics and really rally behind it not just as a fad initiative but as something that becomes part of our culture and DNA and we called it ecomagination. We said that we are going to invest more in environmentally-friendly technologies, we are going to do our job to try to inform the public on issues related to the environment, and then we are going to try to walk the talk and reduce our own greenhouse gas emissions as an enterprise and that was launched a handful of years ago and it was just a smashing success -- great for our employees, great for our customers, and really it was a revitalization of our culture around environmental sustainability.

A couple of years ago Jeff sort of took a step back and said health care is going to be -- it is, and will continue to be -- a pressing global problem of tremendous importance and magnitude and not only are we a big health care technology company but GE pays a tremendous amount of money, several billions of dollars in health care costs each year. He said we can be doing more as the General Electric Company to lead in the evolution of health care. So in a parallel construct we launched this initiative called healthymagination. Yet again, as a good operating company, what are we trying to do? It’s really focused around bringing innovative technologies -- this doesn’t mean high technologies it means innovative technologies. Some may be high technology some may be low technology but innovative technologies to help improve quality of care delivered, reduce the cost of care delivered and improve access, and we are going to put about six billion dollars of investment into technologies globally aimed at these three metrics. We’re doing our job to inform the public about issues related to health care. We launched the largest advertising campaign in the General Electric Company’s history, I believe, earlier in the year concurrent with the Olympics with some really lovely -- some times funny, sometimes poignant -- commercials around health care, I think they were very well received. And so healthymagination is more than an initiative -- it’s a major focus for the company, again trying to get at culture, DNA, around thinking about health care differently and making sure that we as the General Electric Company are doing our part trying to help the world improve on cost, quality, and access to health care.

David Harlow: OK, well thank you. So any last words on what you are doing now and how you see your division moving forward under the HITECH Act and now under the new health reform law?

Earl Jones: Well certainly we’re very happy about the HITECH Act -- that’s been great for the industry. I don’t know there is a whole lot of – well, some money has been flowing down, so it’s been great, but more than anything else it really has gotten people galvanized and motivated and gained some momentum around changing the landscape of health care IT, which is great. But, by the way, this is happening on a global basis, so sometimes we like to think about the world as being the 50 states here, but there are some folks in China, in Singapore, in India, in the Middle East, in Saudi Arabia, in Europe, in Brazil, I mean folks are really doing some innovative things with health care IT globally and so eHealth is absolutely playing in that arena. We are very focused on delivering value for our customers here domestically, but frankly just very focused and very passionate about the opportunities to help health systems and countries on a global basis as well. With reform, with health care, HITECH Act, with all that, the challenge that we have, and I think other people may have it as well, is not to get carried away – we’ve got to stay good at what we do, which is sort of sticking to our knitting, if you will, which is working with hospitals, working with IDNs, working with health information organizations, but working with folks around delivering real, concrete, measurable value. And I think as long as we do that and stay focused on solving the problems and pain and enabling new care delivery models, enabling new transparency and performance reporting -- as long as we stay focused on what we do well, I think we feel very good about the future. We love all the reform, we love the HITECH Act, but I don’t want to get carried away and focus on chasing that money. I think we’re just going to stay focused on trying to solve hard problems for our customers.

David Harlow: Sounds like a plan. Thank you very much. I have been speaking to Earl Jones Senior Vice president and General Manager for eHealth at GE Healthcare IT and this again is David Harlow on HealthBlawg, thank you once more.

John Glaser, CIO of Partners Health Care, speaks with David Harlow about health IT and meaningful use in a $7.9 billion health system

What does a large health system CIO worry about if his system is already fully up to speed in the day-to-day use of EHRs?  Using them in ways that improve communication of information across a diverse group of clinicians, and that enable the integration of additional interesting and useful data as time goes on -- such as the integration of genetic testing data into the diagnostic and treatment logic built into the EHR.

John Glaser explains how Partners uses its EHR system to leverage knowledge for the benefit of patients, and describes some of the ways in which decision support systems are being used today and may be used in the future.  

Tools in place at Partners now:

[T]here is for example a monthly report put out on dozens and dozens of quality measures and they are coded red, yellow, green depending where we are relative to the national benchmarks and that . . . allows us to focus on areas that do need some attention.  In addition to that you can use the systems like CPOE or the EHR to introduce logic at the time of care, so to make sure that an order is a safe order or that an overdue health maintenance activity has been noted and followup is occurring.

...

[L]argely at this point focused on cancer . . . we do have decision support that says before you order this chemotherapeutic agent you should run this genetic test because that will tell you whether the agent will or will not be successful.  We do have a piece of software called the patient genome explorer which sits right beside the results viewer for chemistry results, and this allows you to look up genetic test results and understand the ramifications for the patient you are treating.

Glaser acknowledges the difficulties that may be faced by smaller provider organizations in gearing up to meet the meaningful use criteria related to EHR implementation, but notes that for him, there is no separate ROI calculation for implementation of these tools, saying

I mean, what’s the ROI of email? Beats me but, nonetheless, few of us could get through a day without it.  At other times the ROI is quite tangible because you could say golly, we are cutting real costs here or making real revenue.  At times the outcome is tangible - it may not always be expressible in terms of dollars.  You can, but that’s not the point. . . .  So I think we will see a return broadly speaking . . . .  I think at the end of the day it is one of those things which you say listen, this is a given.  It is hard to imagine that we would sit here today and say if ten years from now we ran our health care system on paper that would be okay or a good thing.

The Partners team has the luxury of being able to spend significant time on R&D, and Glaser says that

we do have some people who are looking at different techniques to be applied to putting a layer of logic on top of complex and idiosyncratic data coming in, and teasing out that sort of data. So, for example, if you know that there are, let’s say, 200 notes [in a patient's EHR, entered by a variety of clinicians] and that the patient is being seen by a cardiologist, you just have the system be able to identify that subset of notes that appear to have a bearing on the consultation in question and being able to categorize those notes for the doctor, so that he or she can say jeez, of the 200, there are five that are related to prior cardiac events, there are four that are related to what appear to be cardiac procedures . . . to help to filter through and surface that subset of note, or other data, which appears to be the most salient.  So we are learning.  We are trying a bunch of different techniques to figure out how to do that.

And a final note on meaningful use: The transcription service I use (which is based in India) rendered "interoperability" as "entrapped ability" in the first draft of the transcript -- an unwitting bit of wry commentary on the need to unlock the potential of EHRs through the kind of broader thinking shared in today's interview.  I think you'll find it to be an interesting read or listen. 

The audio file of my interview with John Glaser (about 25 minutes long) is available for download/podcast.  A full transcript is at the end of this post (and in the linked John Glaser, CIO, Partners Health Care, HealthBlawg interview transcript).

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

HealthBlawg :: David Harlow’s Health Care Law Blog
Interview of John Glaser, CIO of Partners Health Care

March 3, 2010

David Harlow:  This is David Harlow at HealthBlawg, and I have with me today John Glaser, the CIO at Partners Health Care in Boston.  Hello John, thank you for joining us.

John Glaser:  It’s a pleasure, David.

David Harlow:  So Partners Health Care - for those of you who are not familiar with it - is an organization that includes ten hospitals, 7000 physicians, 45000 employees.  Have I got that right, John, more or less?

John Glaser:  Yes, you do.

David Harlow:  And John has been the CIO at Partners for quite some time.  He’s also been acting as an advisor to the ONC on implementation of the HITECH Act since last spring.  We’ll try to steer clear of government-related issues today and focus on issues at Partners.  So John, moving beyond the numbers, how would you describe Partners Health Care and what it means to be CIO of Partners?

John Glaser:  Well, Partners Health Care has got a couple of attributes.  One is it’s large, so we’ve got another number to put in there, it’s about 7.9 billion in revenue and in addition to its hospitals and extensive array of outpatient clinics, physician practices and 90 key facilities, it’s a very large, very complex organization.  It’s also quite academic given its two founders [Massachusetts General Hospital and Brigham and Women’s Hospital, both of which are major teaching affiliates of Harvard Medical School].  So it has tremendous resources, tremendous talent, some world class organizations, and using those assets it can be a challenge at times to line everybody up and have the organization move in a concerted direction. I guess that’s true of all large organizations, although we certainly feel that at Partners. And while that can be difficult at times, the fact that there is such talent, and there is such a commitment to the mission of care, research and education makes it worthwhile and enables us to accomplish - from time to time - some very remarkable things.

David Harlow:  Would you say that things have gotten easier as the association has lasted longer, or more complex as it’s grown larger? You’ve been with the organization quite some time now and I was wondering how things have changed over the years.

John Glaser:  Well I have been for quite some time. I’ve been the CIO since 1995 and so that’s a little over 15 years.  And prior to that, CIO at the Brigham for another seven years, so 22 plus years in the family as a whole.

So I think it’s very clear that as the organization has matured and has begun to understand how to work together, that it is more effective at working together, bringing together very disparate organizations, large AMC’s, small community hospitals, for example, bringing together people who may or may not have a track record of working together.  So it is better at moving as an integrated system than it has been in years past.

On the other hand, the challenges it has to address have become more significant so there are greater cost pressures today than there were ten years ago and there are greater quality pressures than there were ten years ago.

The pace of medical innovation and events are more significant. As our community of clinicians and others have become more experienced with the technology, they also become more demanding and more sophisticated.  So the demands and the expectations are higher and have been paralleled by a growing ability to work together as a collective.

David Harlow:  So going back to a couple of things that you said specifically, I’m wondering if you could tell us, how does the health information technology function within Partners help to enable the organization to deal with some of these issues - whether it’s adherence to quality measures; whether it’s dealing with payment issues - and, how does your function, your part of the organization’s function integrate with the clinical function?

John Glaser:  Well, there are a number of ways in which we try – and, at times, succeed - in helping Partners address these challenges.  At times we take processes and make them more efficient and save money in addition to having those processes work faster, be less error-prone, etc.

By providing data that comes out of the EHR, the organization’s in a much better position to look at variations in care practices and identify those practices that are more efficient than others, that are of better quality than others.  I actually have the data to assess quality and to then deal with that variation in whatever manner it chooses to do so.  So the fact that you have clinical data, and data that also brings along the cost component of that clinical data, allows us to look at where we need to do some work, where we don’t.

So there is for example a monthly report put out on dozens and dozens of quality measures and they are coded red, yellow, green depending where we are relative to the national benchmarks and that again allows us to focus on areas that do need some attention.  In addition to that you can use the systems like CPOE or the EHR to introduce logic at the time of care, so to make sure that an order is a safe order or that an overdue health maintenance activity has been noted and followup is occurring.

So through the transactions systems one has the ability to carry out a lot of the guidance and recommended care that comes out of the data activities.  So there is a series of analysis capabilities and transaction capabilities that help address this complicated mixture of cost, quality and safety.  But also in addition to that is the ability to adapt.  So for example it’s fairly clear in the next several years - 3 to 5 for example - genetic testing will be increasingly a lager component of health care because of our greater understanding of your genetic makeup and how it guides treatment decisions, or what disease you really have.

And so the ability of systems to adapt and to capitalize on advances in medical care, to capitalize on advances in care models such as the medical home or accountable care organizations, and also capitalize on the gains that new technology can bring - that we are trying to make sure that our infrastructure and applications are able to move as the collective environment moves.

David Harlow:  Now I understand a few years back you established together, Partners established together with Harvard Medical School a center for genetics and genomics and is this what you are talking about, is this informing some of the care management, is there genetic testing data that’s included in patient profiles that can be used to guide clinical services?

John Glaser:  Yeah, we formed several years ago what is now called the Partners Center for Personalized Genetic Medicine, and it has two major roles.  One is to facilitate research into the genomic basis of disease or treatment variability.  So for example if you are clinically depressed and given an SSRI, it works well a third of the time, medium well a third of the time and not at all a third of the time, and so helping investigators determine whether there’s a genetic underpinning to that.

So we’ve learned a lot and this will help accelerate research into how genes contribute to our disease and our treatment success for example.  In addition to that, that is also not only because of the advances themselves but the knowledge of how do you store genetic test results and what does genetic decision support look like, how do you present genetic test results to the clinician.  It’s begun to make its way into the clinical systems, largely at this point focused on cancer, but we do have decision support that says before you order this chemotherapeutic agent you should run this genetic test because that will tell you whether the agent will or will not be successful.  We do have a piece of software called the patient genome explorer which sits right beside the results viewer for chemistry results, and this allows you to look up genetic test results and understand the ramifications for the patient you are treating.

David Harlow: Is there an overlay now with the GINA legislation on top of HIPAA in terms of privacy requirements and protection requirements, encryption, others, relating to genetic information that’s on the system or does HIPAA deal with that sufficiently?

John Glaser:  Well, there are clear genetic privacy ramifications for all of this and it gets complicated.  I will give you two examples.  If a genetic test were to say that you or I were at great risk of a debilitating form of dementia, one would say, well, I ought to keep that private, because of – for lots of different reasons.

On the other hand, a genetic test result that says you will be a slow metabolizer of sulfa drugs, you might say -- jeez, I’m less worried about loss of job or loss of insurance based on that. But I do want my doctor to know because I do want to make sure they don’t inadvertently overdose me on a particular drug.  So genetic test results actually span the gamut of those which are highly sensitive to those which I think most people regard as no more sensitive than a blood potassium reading.

And given that, nonetheless, what we have decided to do is to treat any genetic test result as being in the same category as the most sensitive data and so this is HIV data, this is mental health data - we treat that and provide both the policy procedure the consenting processes for example but also the IT controls over that type of data that we would - I think perhaps society may evolve to the point where it categorizes genetic data into different forms or buckets of sensitivity.  But until that’s the case, we will treat it as the most sensitive.

David Harlow:  So you’re not looking to get patient consent to disclose certain types of genetic information like for example the way you would…

John Glaser:  Yeah just as you would on any sort of highly sensitive set of data.

David Harlow:  Okay.  One area of interest at Partners is the electronic health record and the use of electronic health records over time, which, I understand, is a home grown system.  Is that right?

John Glaser:  Yes -  the bulk of our, we have approximately 4200 physician users of our outpatient EHR, 85% use the homegrown version and 15% use a mix of GE and a couple of other systems that have been in place for quite a while.

David Harlow:  And what would you recommend, having had the experience with both?  What words of wisdom would you have for other providers who are looking at implementing EHR systems in this era of HITECH incentives?

John Glaser:  Well I think these systems, whether you build them yourself or you buy them from the market - and most people buy them from the market, and most people should buy them from the market - these are a challenge to get in place.  They are very invasive to the workflow and so a physician, or a nurse practitioner or any other health care professional who now is documenting on them, writing orders on them, reviewing results, - it’s very invasive.  It’s not something that is kind of off to the side.

And as a result there is a great deal of demand for systems that have a lot of strong features, functions, but also are very usable and quick.  It requires that workflow be understood, changed if necessary and that includes where do you place printers and things like that. It requires a good deal of training and some strong support, and I think practices who undergo this should be prepared for several months - and it seems to vary at least in our practices, sometimes it’s as long as six months, sometimes it’s short as two months - where there is a form of disruption and people just getting their feet wet and getting oriented to this.  So there are a lot of demands on the systems, there are a lot of demands on the implementation process and the workflow change process and there are a lot of demands on support, and obviously there are a lot of demands on the practice who goes through this.  Nonetheless once you get through that we have never had any clinician of any form say I wish I could go back to paper.

They clearly see that the care is better, that there have been some efficiencies gained, there’s been some challenges.  Sometimes it takes longer to do certain tasks.  But nonetheless it is a journey that is - both from the care perspective and the cost of care overall but also the ability of the providers to say I’m practicing good medicine, must be able to say that.  So I think it is a hard journey but it is a worthwhile journey that the federal government incentives recognize the importance of us collectively moving in that direction.

David Harlow:  Part of the issue is the interoperability, the opportunity for free exhange of data from one provider’s electronic health record to another, to be able to follow a patient across care settings.  Given the size and the scope of the Partners network, I’m wondering how important the development of RHIOs and health information exchanges are to Partners? Are patients who are seen within the Partners’ network receiving all of their care within the network?

John Glaser:  No and I think that some networks are more closed than others; the VA, Kaiser, are more closed than others. For example, almost 50% of our referrals – remembering we’re academic at our core - come from physicians outside of Partners. So we have extensive movement of people in and out of Partners, some stay within the Partners community but a lot don’t.

So I think this notion of exchanging data is critical, and it runs a sort of a gamut, it runs a gamut of giving the referring physician access to the core institutional systems, to the gamut of the movement of a structured transaction - maybe it’s an operative note, maybe it’s a set of chemistry results - from one system to the other.  At times we have clinical affiliations which are very strong and we wind up with shared scheduling systems, shared email systems and much more extensive integration and interoperability.

So I think the basic rubric of putting out standards and encouraging the exchange is a very important set of activities.  It creates parallel issues, it creates issues of making sure that the privacy and the security steps necessary are put in place, because we now have different privacy and security challenges when this occurs.  It also places a challenge on the providers who now may be going into their EHR and seeing lots and lots of data from lots and lots of other providers and saying holy smokes, I have a brief period of time with this patient, but I have 200 notes and 180 of them are not mine.  How do I wade through these and determine which ones are the most important? So a knowledge management function, and a decision support function, and a set of guidance using all of the above, might help the physician zero in on the most clinically relevant - becomes a challenge.  So there is, there is great gain to be had. It does bring some parallel challenges that we still need to address.

David Harlow:  Have you seen some movement in the direction of being able to wade through those kinds of notes, the kind of volume of notes there might be from outside providers, any sort of knowledge management systems that you are using or that is on the market today?

John Glaser:  Well, I don’t know about on the market.  We are, as an IS group, unusually academic in our approach - about 15% of our staff are funded by federal grants or through industry partnerships to explore leading-edge topics in healthcare IT and they run the gamut from what is known as telemedicine, to genetic medicine, to knowledge management – things like that.

But we do have some people who are looking at different techniques to be applied to putting a layer of logic on top of complex and idiosyncratic data coming in, and teasing out that sort of data. So, for example, if you know that there are, let’s say, 200 notes and that the patient is being seen by a cardiologist, you just have the system be able to identify that subset of notes that appear to have a bearing on the consultation in question and being able to categorize those notes for the doctor, so that he or she can say jeez, of the 200, there are five that are related to prior cardiac events, there are four that are related to what appear to be cardiac procedures.  So anyway to help to filter through and surface that subset of note, or other data, which appears to be the most salient.  So we are learning.  We are trying a bunch of different techniques to figure out how to do that.

David Harlow:  On a related note, some of the tools and products that have been on display at HIMMS this week or announced at HIMMS this week down in Atlanta – I’m wondering whether there are categories or particular types of tools coming out of that conference and from the exhibitors there that are of particular interest to you, something that catches your interest?

John Glaser:  Well, I was at HIMSS for only a day and I was only briefly on the exhibit floor so I didn’t get a chance to see what was going on.  I think in general obviously the major topic is the federal stimulus funds and how to address those.  So I think tools that invariably help providers to meet those meaningful use requirements or the standards and particularly help the smaller physician practice, the smaller hospital, which have very low adoption rates and have in general, not entirely but in general, not been as well served by the market as the larger organizations as technologies that are directed there are of great interest.  Anyway I didn’t have a chance to personally see a whole lot of the exhibit floor.

David Harlow:  Fair enough. What would you identify now as areas of opportunities as well as areas of challenge in adopting not only EHRs but also other health information technology tools across the health care spectrum?  Maybe speaking from your experience within Partners but also as you mentioned looking at some of the smaller providers which is where I think collectively we’re hoping there will be greater adoption.

John Glaser:  Well I think broadly, and across the country, we still have the challenge of getting higher adoption rates and now meaningful use of those technologies so those of you folks listening to this know the rates as well as I – but they’re low.  So that challenge which has been with us for a while, it’s still with us, and perhaps we’ll have a series of factors that will cause us to pursue it more aggressively and I think in particular, as has been mentioned before, it’s the smaller provider organizations which need the most innovative approaches to the delivery of these systems in helping those patients, and remembering that two-thirds of all of outpatient visits occur in physician practices of three or fewer docs. That’s where the bulk of care occurs in the US. So there is - that challenge is going to be with us for quite some time - several years.  And all that implies - the difficult work of implementation and some of the comments mentioned earlier.  In addition to that it is also clear that there are some opportunities emerging or at least will be different as result of broad adoption of interoperable electronic health records. One is itself the management of interoperability at scale, protection of privacy, the assurance of standards, helping docs deal with large volumes of information. And so there will be a series of things we’ll have to do and understand this is when you have interoperability at scale, what gain really occurs but also what challenges are present or revealed that we still need to develop tactics and tools to deal with.

The other is that there is a clearly going to happen or beginning to happen now, large accumulations of data about patients which can be used for comparative effectiveness research, clinical research, post-market surveillance of medications and devices, public health surveillance, etc.  And I think we have a lot to learn about how to manage that data, not only the protection of privacy but also how to distill patterns out of data which is often conflicting, noisy or incomplete.

The third area - we still have a lot of ground to cover - is how best to engage patients; we use the technology to engage patients - personal health records, personally-controlled health records, a lot of targeted applications where you can measure your blood sugar or your blood oxygen saturation, or whatever it might happen to be - people with chronic disease; we have a lot to learn there.

So lots of promise there but still relatively small levels of adoption and very limited understanding of how much of a contribution this will make to the management, let’s say, of a chronic disease, or the gradual improvement of health.  So there are a couple of big areas.

I guess one other big area is - if we have large bases of knowledge or decision support across wide ranges of systems - is managing this knowledge base.  A knowledge base of rules or order sets or templates, it is now quite sizable, which changes from time to time.  And I think one of the factors of our growing knowledge of the relationship between the genome and our health is whatever volume of decision support rules you think there are now – it’s going to go off the charts as that becomes increasingly incorporated into medical practice, so how best to manage that knowledge base and to ensure that it’s effective remains a daunting challenge.

So, as we address the core one, getting these systems in place and used well, and broadly looking at a series of challenges coming up that will result from the broad use of interoperable electronic health records.

David Harlow:  Do you see a direct correlation between the advances in the systems and the return on investment, if you will, or is this just part of the infrastructure that has to be in place in the future? Is this just like you need to have a telephone, you need to have this…

John Glaser:  Well I think it’s a combination of things. One is technology at the end of the day is a tool and, per se, guarantees no ROI and you see that in some of the studies they’ve done or sometimes great gains in patient safety have occurred, sometimes they haven’t, and sometimes the organization runs more efficiently and sometimes it doesn’t.

So we have very variable outcomes and partly because it’s not the tool that delivers the outcome, it’s the way that it is implemented and how effective it is.  So we will continue to see that because again it is at the mercy of the skill of change management and leadership and a wide variety of other things so, given that, we also recognize that that the nature of the return is really diverse, at times it is very intangible - I mean, what’s the ROI of email? Beats me but, nonetheless, few of us could get through a day without it.  At other times the ROI is quite tangible because you could say golly, we are cutting real costs here or making real revenue.  At times the outcome is tangible - it may not always be expressible in terms of dollars.  You can, but that’s not the point.  So if you are, if you deliver safer care, you can certainly measure the dollars there but those aren’t really the measures that people are focused on - or improved service.

So I think we will see a return broadly speaking - realizing how tangible or intangible, how dollarizable or not dollarizable it is, to the sort of settings in which it’s delivered.  I think at the end of the day it is one of those things which you say listen, this is a given.  It is hard to imagine that we would sit here today and say if ten years from now we ran our health care system on paper that would be okay or a good thing.

I think there are very few people who would stand up and try to carry that argument forward - at a face validity level, and at an empirical level, it just doesn’t make sense.  So I think the basic idea that if we really want to make extraordinary gains in the care in this country you have to have this foundation in place.  The foundation doesn’t guarantee it but it’s hard to imagine that you would accomplish it without it.

David Harlow:  Well, thank you very much.

John Glaser:  My pleasure.  I hope this is interesting and informative, and I appreciate the time.

David Harlow:  It certainly is.  I’ve been speaking with John Glaser, Chief Information Officer at Partners Health Care in Boston on implementation of health information technology and the improvement of health care. Thanks again, John.

John Glaser:  All right. Thank you, David.

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HIPAA enforcement: Business Associate Agreement rulemaking needed first - time to plan ahead

After learning of comments on HIPAA enforcement made by a member of the HHS OCR legal staff at an ABA meeting on health care issues, I contacted him directly.  Adam Greene confirmed that HITECH Act changes to HIPAA rules regarding business associate agreements will be implemented through standard notice and comment rulemaking, noting that this has been OCR's public take on the issue.  Thus, a notice of proposed rulemaking will be published "shortly," followed by promulgation of a final rule after a comment period.  Even thought the statute calls for the BAA provisions to be effective this month, they clearly will not be.  The breach notification and penalty provisions are already the subject of an interim final rule, so they are in effect. 

As I wrote several months ago,

"business associates" under HIPAA are now required to implement policies and procedures to maintain privacy and security of PHI, parallel to those that have been required of "covered entities" under HIPAA since the beginning. All business associate agreements and notice of privacy practices (NPPs) will have to be updated to account for the new requirements before February. Health care providers that wish to distinguish themselves should consider revising their NPPs to highlight the ease with which they will make copies of records available to patients. This is a bone of contention for many patients, and ensuring that patients' rights to their records are easily exercised could be a way to build goodwill among patients and potential patients.

Thanks to Bob Coffield for pointing to the post on the ABA meeting and raising the question.

I urge all covered entitites and business associates to take heed of these new requirements and begin planning now for implementation of the soon-to-be-released regulations.  Don't sit back and end up being made an example of by OCR (e.g., with a million-dollar fine) or by a state attorney general.  Contact the HealthBlawger now.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Healthcare Communications and Social Media - First Anniversary Tweetchat

Sunday night, Dana Lewis (twitter handle: @danamlewis) hosted a special two-hour edition of the weekly Healthcare Communications and Social Media Tweetchat to mark its first anniversary.  There was a guest moderator -- Lee Aase (@leeaase).  There was a raft of special guests: Nick Dawson (@nickdawson), Greg Matthews (@chimoose), Jonathan Richman (@jonmrich), Liza Sisler (@lizasisler), Jeff Livingston (@macobgyn), Christine Kraft (@christinekraft) and Val Jones (@drval).

While the background and institutional interests of the speakers and the participants is incredibly broad (integrated health care delivery system to payor to digital health care marketing consultant to physician to health care IT consultant . . . ), the focus on the group has been pretty clear over the past year: harnessing the power of social media for the benefit of the patient -- providing information to patients, empowering patients and enabling patient choice.  While part of the equation is, naturally, an effort to develop outreach that results in more volume at a particular health care provider, there is great attention paid to the need for authenticity and trust in this particular sort of online relationship.  As I always say, social media is just "one arrow in the quiver," but it is a relatively new and potent one, so this sort of examination of its uses is valuable. 

Read about the history of this weekly tweetchat, known by its twitter hashtag #hcsm -- which many of us heard vocalized for the first time Sunday night, as "Hic-Sum" as the chat also took place via Blog Talk Radio (the two-hour broadcast is archived and may be heard here; beware - audio starts as soon as you open this link).

There were many participants in the discussion as well -- participating via twitter at #hcsm and on the Blog Talk Radio chat room.  The ongoing discussion owes a debt of gratitude to Tom Stitt (@tstitt) for pulling together the infrastructure and to Meredith Gould (@meredithgould) for pitching on Sunday night, in particular.

I was tickled to be included in the #hcsm timeline: The legal #hcsm tweetchat in June featuring Mayo lawyer Daniel Goldman (@danielg280) and the HealthBlawger, David Harlow (@healthblawg), "reaches 1000+ tweet per hour intensity and is nicknamed the 'fire hose' #hcsm chat."  (See my post on the legal #hcsm chat.)

Here's to another year of interesting discussions online . . . and otherwise, as connections made via twitter leak into that parallel universe we call real life.  I look forward to making more of those connections as time goes on, and I encourage those of you not already following the health tweets mentioned in this post to start following them on twitter; and who knows, maybe we'll hear from you at the next #hcsm tweetchat.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting