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40 posts categorized "Patient safety"

December 03, 2014

Down, Down, Down: Avoidable Errors, Uninsurance, Cost Inflation

Upside down churchToday was a good news day. The headlines, at least, would have us believe that we are making great strides in achieving the Triple Aim, dealing with quality, access and cost issues.

Exhibit A: Deaths due to Healthcare-Acquired Conditions are Down. Per the WaPo, AHRQ says:


Hospitals reported 1.3 million fewer hospital-acquired infections in all between 2011-2013 compared to the rate of mistakes that hospitals made in 2010, according to the report from the Department of Health and Human Services. That represented a 17 percent drop in hospital errors from 2010, but about 12 percent of all hospitalizations as of 2013 still experienced an adverse event during the course of care.

The reduction of these avoidable incidents — such as falls, pressure ulcers, adverse drug events and more — meant $12 billion in savings to the health-care system between 2011 and 2013, according to HHS.

Continue reading "Down, Down, Down: Avoidable Errors, Uninsurance, Cost Inflation" »

October 14, 2014

Apple HealthKit - Epic Integration at Ochsner Health System - David Harlow Interviews Dr. Richard Milani

Apple-healthkitThe first health system to announce that it had integrated HealthKit into its Epic EHR is Ochsner Health System in Louisiana. It is a 12-hospital, 40-clinic operation with over 900 physicians. I spoke recently with Dr. Richard Milani, Ochsner's Chief Clinical Transformation Officer. He was enthusiastic about the improvements in clinical outcomes realized to date through homegrown integrations of things like Withings scales, and sees significant expanded potential using the Epic-HealthKit integration including dissemination of data to clinicians for more efficient and effective management of care and presentation of data to patients in a way that may motivate behavior change to improve health status.

Continue reading "Apple HealthKit - Epic Integration at Ochsner Health System - David Harlow Interviews Dr. Richard Milani" »

April 07, 2014

FDASIA Health IT Report Issued; Comments Welcomed on Three-Agency Approach

Pages from HealthITreport_FINALThe FDA, the FCC and ONC issued a long-awaited joint report with a proposed strategy and recommendations for a risk-based framework for regulation of Health IT.

The report identifies four key priority areas and outlines next steps to take in each area:  

I. Promote the Use of Quality Management
II. Identify, Develop, and Adopt Standards and
Best Practices;
III. Leverage Conformity Assessment Tools; and
IV. Create an Environment of Learning and
Continual Improvement

This report should be read together with the FDA framework for regulation of mobile medical applications which was supposedly up in the air pending release of this report. It now seems that they are directed at related, but different, parts of the ecosystem. Both are part of a bigger story, including pending legislaton.

Continue reading "FDASIA Health IT Report Issued; Comments Welcomed on Three-Agency Approach" »

March 27, 2014

Unlocking the Power of Health Data

3769904793_e08235af58_zA Perspectives piece I wrote was published this week by iHealthBeat - Unlocking the Power of Health Data. In it I argue for patient-controlled sharing of rich data, as opposed to HIPAA-regulated stripping of identifiers in order to eliminate the risk to patient privacy as data is shared for research and other purposes. Googler Larry Page and Josh Stevens of Keas have argued recently in favor of broader uses of health data, but the issue of HIPAA keeps coming up in those conversations. Most connected patients seem comfortable with the idea of sharing health data, and as more of us get connected, this sentiment is only likely to spread.

As I wrote at iHealthBeat:

I have discussed the patient donation of data before, and the first objection I heard was from a data scientist who worried that the volume of patient records collected in this manner would be too small to yield any meaningful insights. While this may be true at first, I believe that over time patients will come to prefer to set their own limits on data sharing rather than be stuck with the one-size-fits-none approach available under HIPAA. In addition, the data made available through these repositories will be more valuable than that available as de-identified data for research precisely because there are more identifiers attached.

Are we ready for a new paradigm in data sharing and big data analysis?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

photo: flickr cc Tripp

August 06, 2013

Hacking HIPAA - Join Us!

Hacking-hipaa_edited-1For years, a common refrain in the health care space has been that regulations are constraining innovation.

The latest in a long list of rules that constrain health IT development are the HIPAA/HITECH regulations. (Read all about them here on HealthBlawg.)The Federales begin enforcing these regs on September 23, 2013

HIPAA was not intended to make things worse, but the rules can lead organizations to be very conservative in their actions.

If patients want to use email, standard SMS, non-HIPAA compliant consumer device data, or applications that run on the cloud - they should be able to. Fortunately, there is a way to make this possible.

The object of the Hacking HIPAA project is to create crowdfunded legal forms based on crowdsourced ideas from the Health IT developer community as well as the health care provider and more traditional health IT communities.

Continue reading "Hacking HIPAA - Join Us!" »

May 14, 2013

The FDA Patient Network Website - Pretty Darn Patient-Centered

FDA Patient Network 2
The FDA launched an impressive patient network website this month, after nearly four years of research, focus groups, usability testing and more. The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically. James Valentine, Program Analyst in the Office for Health and Constituent Affairs put it simply and forcefully in a recent telephone conversation: “The idea is to engage the patient community, to have the patient voice heard at the FDA.”

Historically, the agency has been working with patients one-on-one, by phone and email, often when an extremely ill patient is seeking information on clinical trials or access to investigational products. The goal is to broaden the field of engagement. The agency has had patient representatives on its advisory committees since the late 1980s — an innovation that came about as part of the response to AIDS/HIV — and patient involvement in the FDA’s processes were further formalized in the late 1990s, as part of Clinton-era cancer initiatives. There are now about two hundred patient representatives involved in over 110 disease areas.

The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year, according to Valentine. Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants — just as scientific and clinical experts brought into the FDA process are recognized as consultants — and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses.

Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.

While the new website is a gateway to the FDA, Valentine assures us that “the Office of Health and Constituent Affairs is still here to help patients navigate the agency.”

The first FDA Patient Network live chat will be a town hall meeting with staff from the Office of Health and Constituent Affairs on May 21 at 3:00 p.m. EDT. Future chats will feature staff from throughout the agency.

Here’s hoping that the FDA will carry through on the promise of online openness.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

A version of this post first appeared on, the blog of The Society for Participatory Medicine.

March 01, 2013

OIG review finds about 1/3 of all Medicare nursing home stays had inadequate care, care planning or discharge planning

OIGAs part of the US Department of Health and Human Services Office of Inspector General's current focus on nursing facilities, the OIG recently released a report entitled: Skilled Nursing Facilities Often Fail To Meet Care Planning and Discharge Planning Requirements.

From the OIG summary:

Skilled nursing facilities (SNF) are required to develop a care plan for each beneficiary and provide services in accordance with the care plan, as well as to plan for each beneficiary's discharge. These requirements are essential to ensuring that beneficiaries receive appropriate care and safely transition from one care setting to another. Several OIG studies and investigations found that SNFs had deficiencies in quality of care, did not develop appropriate care plans, and failed to provide adequate care to beneficiaries. In fiscal year 2012, Medicare paid $32.2 billion for SNF services. This study is part of a larger body of work about SNF payments and quality of care.


For 37 percent of stays, SNFs did not develop care plans that met requirements or did not provide services in accordance with care plans. For 31 percent of stays, SNFs did not meet discharge planning requirements. Medicare paid approximately $5.1 billion for stays in which SNFs did not meet these quality-of-care requirements. Additionally, reviewers found examples of poor quality care related to wound care, medication management, and therapy. These findings raise concerns about what Medicare is paying for. They also demonstrate that SNF oversight needs to be strengthened to ensure that SNFs perform appropriate care planning and discharge planning.

(Emphasis added.)

The OIG found, and CMS agreed, that CMS administrative enforcement efforts need to be beefed up on care planning and discharge planning, and that payment for services needed to be more closely tied to quality of services.

The negative findings implicate about 1/3 of skilled nursing facility stays, and over 15% of Medicare payment for skilled nursing facility stays.

In other arenas where health care providers are found to be out of compliance with Medicare conditions of participation, the Department of Justice tends to initiate actions under the False Claims Act to recover Medicare payments. (One example that leaps to mind involves the physician supervision requirements for diagnostic imaging under the OPPS rule.) Clearly, recoupment of $5.1 billion per year would be disastrous for the nursing facility sector, and since the OIG's recommendations included a mandate to clarify the regulations it is an unlikely result of this report. However, nursing facility operators should take note of this report and begin to address these areas of concern sooner rather than later.

The current report comes on the heels of a report issued late last year highlighting Medicare billing errors by nursing facilities that resulted in overpayments of $1.5 billion in 2009.  CMS committed to take appropriate action following receipt of that report, which could include recoupment of overpayments.

The OIG is currently looking at adverse events in skilled nursing facilities, which will be the subject of an upcoming report.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

December 03, 2012

Gimme My Damn Data - The ICD Edition

The latest news story to examine the issue of patient access to implantable cardiac defibrillator data (a variation on the theme of “gimme my damn data”) is an in-depth, Page One Wall Street Journal story featuring Society for Participatory Medicine members Amanda Hubbard and Hugo Campos. They have garnered attention in the past – one example is another piece on Hugo on the NPR Shots blog about six months back. The question posed by these individuals is simple — May I have access to the data collected and/or generated by the medical device implanted in my body? — but the responses to the question have been anything but. It is important to note that not every patient in Amanda’s or Hugo’s shoes would want the data in as detailed a format as they are seeking to obtain, and we should not impose the values of a data-hungry Quantified Self devotee on every similarly-situated patient. Different strokes for different folks.

The point is that if a patient wants access to this data he or she should be able to get it. What can a patient do with this data? For one thing: correlate activities with effects (one example given by Hugo is his correlation of having a drink of scotch with the onset of an arrhythmia — correlated through manual recordkeeping — which led him to give up scotch) and thereby have the ability to manage one’s condition more proactively.

We can get copies of our medical records from health care professionals and facilities within 30 days under HIPAA — and within a just a few days if our providers are meaningful users of certified electronic health records (it ought to be quicker than that … some day). In some states now, and in all states sometime soon (we hope), we can get copies of our lab results as soon as they are available to our clinicians.

Data from implantable medical devices is not covered by HIPAA until it is sent to the patient’s physician (on a periodic basis and usually in edited form — other data is typically retained by the device manufacturer) and entered into the patient’s medical record. It is, rather, governed by FDA rules, and the recent attention to this issue has prompted an FDA spokesperson to say that it would review a plan to give data directly to patients, but that data should be directed to physicians who can interpret it for patients. This is where the action will be in the future: the FDA could develop a framework to allow sharing of this data directly with patients. (The data is collected wirelessly in patients’ homes from the implantable devices.)

Not surprisingly, earlier this year, a Medtronic exec referred to the data in question here as “the currency of the future.” There is clearly a market for the secondary use of patient data — on a de-identified, or anonymized basis — for a variety of purposes, and this is the “big data” we are all hearing about so much lately. (The HIPAA enforcers at HHS recently released guidance on the de-identification of patient data for secondary use — i.e., use for research purposes.) There is value to be extracted from big data, and the question is: Who owns the value? Who owns the data? Suffering as I do from the professional disability of being a lawyer, I am reminded of Moore v. Regents of the University of California, the 1990 California Supreme Court case that found that Mr. Moore, a cancer patient who sought to share in the profits for the commercial cell line developed from cancer cells in a tumor removed from his body, had no property rights in his discarded body parts. Moore could perhaps be read to support the device manufacturers’ perspective that there is no value in the data coming from the implantable device until it is processed by the manufacturer.

Another perspective would be that each patient has a property right in the data generated by his or her body or implants. There have been a couple of discussions on and elsewhere about the notion of a “green button” or a “rainbow button” that would serve as a mechanism for patients to decide how to share their own data (in those cases, the discussion was focused on EHR data, but the principles ought to be the same here). If I want to share my EHR or device data with all, so that it may be aggregated with other patient data and used in research and the development of evidence-based medicine protocols, then I should be able to do so.  If I want to donate that data gratis, or if I want to see a small license payment collected by an intermediary (a la the Copyright Clearance Center), if I want to permit it to be used with full identifiers, or as a de-identified record, I should be able to do that.

The quest of patients with implanted devices to gain rights to data should not have to be so quixotic. The information in question is subject to a different regulatory scheme than EHR data, but that is an accident of history, technology and politics.  There is no fundamental distinction between a series of MRI images, or a blood test result, and a set of data downloaded from an implantable medical device.

It is possible that we have turned a corner on this issue. It is far from resolved, but the FDA is addressing it — or at least acknowledging it — publicly.

How close are we to resolving this issue? What obstacles do you see ahead? What other sorts of data have remained inaccessible to patients? Where is the next battlefield?

This post first appeared on, the blog of the Society for Participatory Medicine. I chair the Society's public policy committee.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

December 09, 2011

Microsoft GE Healthcare joint venture - A sign of weakness or strength?

Microsoft and GE Healthcare announced a joint venture yesterday (as-yet unnamed), trumpeted as bringing together the best of both companies' offerings in the health care provider market. (More from the NY Times.) Late in the day, I spoke with Brandon Savage, Chief Medical Officer at GE Healthcare, and Nate McLemore, General Manager of Microsoft Health Solutions Group.  They had a great deal to say about the companies' shared vision of the use of platform technology to enable care teams to deliver the right decision at the right time, noting that their core products complement each other rather than overlap.

The centerpiece of the collaboration will be an amalgamation (so to speak) of the two companies' strengths around Amalga (the Microsoft product) and Qualibria (the GE product). Brandon and Nate described the challenges facing these products thus: Qualibria needs to be able to pull in data from multiple sources better (Microsoft can help), and Amalga needs to be able to share best practices across sites better (GE can help).  

Put another way (to quote John Moore at Chilmark Research), Amalga is "more a toolset than a product." McLemore acknowledged that provider organizations need to make a substantial investment in customization in order to realize benefits from using Amalga, and noted that one of the keys to the synergy with GE is that GE can build the applications needed to unlock the value from Amalga for customers who can't or won't do it themselves.  While there have been some providers that have walked away from Amalga, there are some notable success stories (e.g. New York Presbyterian's dramatic reduction in DVT thanks to information extracted and interventions facilitated by Amalga's analytical tools).  (We should note that there a number of products that carry or have carried the Amalga brand; one of them, Amalga HIS, was sold to Orion Health in a deal that should close soon.)

Qualibria (the GE Healthcare product) is a tool to capture and disseminate medical knowledge and clinical decision rules developed by leading health systems and/or by individual client institutions (see further explanation of Qualibria a little more than halfway through the linked post).  

Savage and McLemore emphasized that their current focus is on population health -- Amalga and Qualibria both allow health care providers to manage populations of patients based on the aggregate date crunched by the two systems.  They also focused on the openness of the products they are building -- even though one might think of GE Healthcare as a "legacy" or "big iron" EHR vendor -- and emphasized the ability of legacy EHR vendors to integrate EHR assets in place with the analytics and clinical decision support provided by Amalga and Qualibria.

The scope of the joint venture announced raises two potential regulatory concerns:

  • First, there may be antitrust regulatory review needed before the transaction can proceed.

This is not GE Healthcare's first joint venture.  GE's joint venture with Intel -- kicked off about a year ago -- by contrast, is more focused on the patient, on the individual receiving home health services, and on the hardware that could be left in a patient's home and transmit data to the patient's health care providers, as needed.

It seems a little odd that Microsoft HealthVault is remaining at Microsoft rather than being moved into the new venture, particularly since Microsoft was, within the past year, talking up the integration of HealthVault and Amalga.  It remains to be seen whether HealthVault will follow the Google Health PHR into oblivion.  Peter Neupert, who has headed up Microsoft's Health Solutions Group, will be retiring from Microsoft, and will consult to the new entity on a part-time basis.  

This seems like the end of an era at Microsoft, with a division whose core product was acquired from an entrepreneurial hospital group about six years back.  As GE Healthcare folks would say, it looks like another case of "reverse innovation" -- except this time, instead of looking for reverse innovation from GE Healthcare technologies in developing countries, GE and Microsoft are hoping to do in a smaller setting what they have been unable to do in their corporate home settings.  As the CEO of the GE-Intel joint venture said recently: "My instructions are to drive the bus as if I stole it."  The new bus sounds like it will be driven by GE Healthcare, with a payload of Microsoft HSG IP in an engineering environment driven by Microsoft culture.  We'll have to wait and see whether and when it arrives at its final destination.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 08, 2011

Healthcare Associated Infections: What is the Message, and What Can We Do About Them?


The good people at GE and JESS3 have come up with an HAI infographic.  It's pretty, and it conveys the horrible information that many of us already know -- healthcare associated infections kill about 100,000 people a year, and add $35 billion a year to our collective health care bill (here in the US of A); 5% of hospital inpatients end up with an HAI.

So what do we expect the world to do with this infographic?  The FDA has rolled out new cigarette package warnings, including graphic photos, that are presumably intended to so sicken potential purchasers of cigarettes that they drop the pack of cigarettes and run screaming from the counter.  In more measured terms, the FDA says:

The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and lower medical costs.

But what is the expected public health impact of publishing this infographic?  I would like to see GE, and/or others, fund the public health campaigns that are needed to accompany the release of such information.  GE is already doing some of that, to be sure, but a staggeringly large problem like the one identified here needs more attention.  The federales are trying to move the needle by refusing to pay for the cost of providing health care services required due to HAIs.  The government and providers are likely to be spending a lot of time and resources in line-drawing and finger-pointing, fighting over the dollars at stake, without pulling back and addressing root causes of HAIs in a systematic manner.

And what sort of campaign do we need in this circumstance?  A consciousness-raising campaign, so that (1) the empowered patient can insist on provider transparency, and create additional market forces pulling or pushing providers away from the marketplace that has allowed the preventable HAI count to swell, and (2) engaged providers can work to prevent the preventable HAIs and communicate the value and quality of care that they can deliver to patients and potential patients.

One possible meeting ground for like-minded patients and providers on this issue is the Society for Participatory Medicine (yes, another shameless plug for the Society and its journal, blog and listserv -- full disclosure: I am chair of its public policy committee).  Join us! 

Participatory Medicine is a movement in which networked patients shift from being mere passengers to responsible drivers of their health, and in which providers encourage and value them as full partners.

Again, the infographic may introduce the problem to folks who may not be aware of it, but the real work lies in solving the problem, not just realizing that there is one.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting