Over time, the app maturity model will see apps progress from being recommended on an ad hoc basis by individual physicians, to systematic use in healthcare, and ultimately to an end goal of being a fully integrated component of healthcare management. There are four key steps to move through on this process: recognition by payers and providers of the role that apps can play in healthcare; security and privacy guidelines and assurances being put in place between providers, patients and app developers; systematic curation and evaluation of apps that can provide both physicians and patients with useful summarized content about apps that can aid decision-making regarding their appropriate use; and integration of apps with other aspects of patient care. Underpinning all of this will be the generation of credible evidence of value derived from the use of apps that will demonstrate the nature and magnitude of behavioral changes or improved health outcomes.
We are nowhere near this endpoint -- integration of the use of health apps into health care management -- right now, due to a number of factors.
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
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
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.
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.
Meet the love child of the FDA and the pharma and medical device industries: The Pushmi Pullyu. ACOs and unicorns, step aside; the is the Pushmi Pullyu's day to shine. (It is now a commonplace that an Accountable Care Organization -- a creature of the Affordable Care Act -- is like a unicorn: everyone can describe it, but no one has ever seen one.)
It's been 18 months since the FDA listening session on the use of social media in marketing drugs and devices, and after many months of thinking that some sort of guidance was just around the corner, the FDA decided to release for public comment a description of some research studies it would like to conduct before actually reaching a decision point about guidance for the use of social media in marketing drugs and medical devices. As others have noted, this will take a while. The studies, as described, are also not likely to yield useful, actionable data, in large part because they are hyper-focused on the web of today and the way people use it, and the online activities of the future (including the near future, say two years from now -- optimistically -- when the studies are complete and guidance is issued) will be different. The agency has to be willing to articulate general principles, but it seems paralyzed on that front.
On another front, the Pew Research Center has just released a very useful report: The Social Life of Health Information, 2011, by Susannah Fox (with whom I have the honor to occasionally share space with on the e-patients.net blog of the Society for Participatory Medicine). This study captures a snapshot of the the way we use the internet to solve health problems -- and many, if not most, of us are doing that one way or another. Research conducted by Susannah and the Pew Internet & American Life Project can help folks tailor messages and tactics to be used in the deployment of health care social media -- both in the realm of health care and in the realm of pharma and devices. Perhaps some day (soon!), the FDA will call on resources such as the Pew Research Center to turn around some illuminating studies within a short timeframe. Until then, we're stuck with the pushmi pullyu approach to social media in the FDA-regulated space --regulators and the regulated community looking away from each other and not. (Another aspect of this approach: the FDA uses social media on its own account, yet is uncomfortable with establishing parameters for tis use by the refualted community.)
Even in this ambiguous environment, folks can use social media for some purposes in the world of pharma and medical devices -- carefully, within some safe zones, following some clear locally-developed policies and procedures. I'm speaking on the subject this morning at MassMEDIC. Please let me know what you think:
A surgeon can’t operate without the proper equipment. A clinician can’t
achieve meaningful use of electronic health records without an EHR that
is designed to improve patient care and practice efficiency. -- David Blumenthal
Today, David Blumenthal, Steve Posnack and Carol Bean of the ONC announced the publication of the final (albeit temporary) EHR certification rule. The actual publication date in the Federal Register will be June 24. (Here is the display copy of the EHR Certification Rule; a permanent rule will be forthcoming later this year.)
The technical standards were glossed over on a conference call with ONC this afternoon; the focus, instead, was on getting testing and certification rolling. Organizations or consortia may apply for recognition as testing and/or certification organizations as soon as the rule is published; the goal is to have these entities approved by the end of the summer, so as to keep this train moving. Notably, CCHIT will have to apply, along with everyone else, and CCHIT-certified EHRs are not grandfathered (despite the requests of many commenters.)
Of course, today's action begs the question of when the meaningful use regulation will be finalized (though clearly certification needs to come first).
The question I didn't get to ask on the conference call today (snubbed again!) was whether ONC has been collaborating with the FDA (which has asserted jurisdiction over EHRs as "devices") so that certification under ONC standards will ultimately satisfy FDA as well. I wonder whether FDA will be as willing as ONC to delegate the testing and certification functions out to private entities. One would hope that this will be addressed in the permanent EHR certification regulations coming out soon.
In order to reduce the number of under-doses, over-doses, and misaligned exposures from therapeutic radiation the FDA is taking several steps to improve the safety and safe use of certain radiation therapy devices. Analyses of Medical Device Reports (MDRs) revealed device problems that appear to be the result of faulty design or use error that could be mitigated by the incorporation of additional safeguards. Between December 31, 1999, and February 18, 2010, FDA received 1,182 MDRs associated with the use of radiation therapy devices. Of these MDRs, linear accelerators accounted for 74%, radiation therapy treatment planning systems (RTP) accounted for 19%, and ancillary devices (e.g., radiation therapy simulators) accounted for 7%. The most frequently reported device problems were computer software issues, use of device, and incorrect display. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown.”
A separate analysis of these MDRs for software problems identified 362 MDRs. Of these MDRs, linear accelerators accounted for 66%, RTP accounted for 29%, and ancillary devices accounted for 5%.
It is important for manufacturers to investigate the cause of nonconforming product and analyze factors in addition to use error as part of Corrective and Preventive Actions (CAPA). Such analysis may include an assessment of the correlation between product user interface, controls, or user information and use error.
FDA plans to hold a public workshop on radiation therapy treatment planning, medical linear accelerators, and ancillary devices. Additional information will be published in a Federal Register notice. Topics will include:
New safeguards and other special controls to improve safety;
Possible changes in premarket device testing to provide appropriate assurances of safety and effectiveness, particularly for software; and
Premarket review of all modifications to software.
FDA encourages manufacturers to attend the public workshop to discuss these issues.
The top issue identified by the FDA in this letter is software, and the proposed solution includes possible premarket testing of software (which FDA asserts comes within the definition of "device.") Issues concerning inappropriate radiation doses raised a couple of months ago extend to the use of diagnostic radiology as well, and have led to the proposal for the establishment of a central radiation dose registry. (Testimony at the FDA hearings on diagnostic radiology included a presentation from MITA's Executive Director, Dave Fischer, who was interviewed here at HealthBlawg the week before the hearing, in early March. A second public meeting was held March 30-31.)
The NY Times reported upon the issuance of the FDA letter:
Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, said the F.D.A.’s action did not address what he believed were more serious problems stemming from shortcomings in staffing, personnel competency and hospital quality assurance programs.
“I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. Amols said. “In fact, I’m not sure anybody does. That’s one of the big problems with software. It comes down to a qualified user recognizing that something is amiss.”
Questions about the FDA's ability to regulate software are of great concern since it has asserted the right to regulate software as a device, not only in the context of radiology, but also in the context of electronic health records.
In the EHR context, Jeffrey Shuren, Director of FDA’s Center
for Devices and Radiological Health, has signaled the agency's willingness to step back from asserting the right to require premarket approval of all EHR software -- good news for the market, though maybe not so good for some of the big players in that market, since a PMA requirement could debilitate the market, and limit entrants to large organizations able to bankroll the PMA process and longer time-to-market. See Shuren's testimony at the February 25 HIT Policy adoption/certifciation workgroup meeting, and the transcript, too, for starters.
The idea that the FDA would exercise regulatory restraint and coordinate with the ONC, so that ONC could incorporate FDA requirements as part of the definition of Stage 2 Meaningful Use is very encouraging (two agencies within HHS coordinating their efforts ... wipeout concept, man). I am encouraged that there can be use made of existing systems within government to capture and process incident reports -- though, of course, Shuren makes the point that reporting is only the tip of the iceberg. There needs to be a commitment to addressing issues, and increased transparency. The point was made at the workgroup meeting that EHR license agreements constrain communications among providers about problems and potential improvements. It seems to me that the industry should be encouraging, not restricting, that sort of communication and opportunity for continuous improvement, rather than face more draconian governmental controls.