Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:
- Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
- Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
- Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)
The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.
The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom. FDA release. Report. FierceMobileHealthcare.
Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.
Previously in TTA: FDA finally issues proposed rule simplifying medical device classification
The mHealth Regulatory Coalition, which is a four-year-old alliance of legal and software companies in the health IT/software area, and whose most vocal spokespersons are well-known industry legal counsels Brad Thompson and Kim Tyrrell-Knott of Epstein Becker Green, has come out against the PROTECT Act (S 2007). PROTECT, which was proposed by Senators Fischer and King, would limit FDA regulation of certain ‘low-risk’ clinical software in the interest of fostering innovation and reducing regulatory burden. Original reports indicated that this responsibility would be transferred to the National Institute of Standards and Technology (NIST) [TTA 28 Feb]. According to Mr. Thompson, “The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high risk from the low risk apps using broad terms in legislation.” His example: a theoretical smartphone app designed to diagnose melanomas from photos. PROTECT is being supported by IBM, athenahealth, Software & Information Industry Association, Newborn Coalition and McKesson. The bill also would exempt certain health IT software from being charged a 2.3% medical device tax, which is perhaps the ‘long game’ being played here by the aforementioned companies, as most Washington watchers give the bill as it stands little chance of clearing both houses of Congress and a congressional committee, much less being signed into law. The question remains: how best to speed less clinically significant wellness software to market without logjamming FDA. iHealthBeat summary, Clinical Innovation + Technology, MRC press release
That other three-letter agency, the Federal Communications Commission (FCC), which has shown a distinctly competitive face versus the FDA on Federal healthcare tech policy over the past three years and more, has formed–drum roll–a task force to examine adoption of wireless technologies by health care organizations. Connect2HealthFCC will “identify regulatory barriers and incentives to expand the use of wireless health technologies; and strengthen partnerships with stakeholders in the telehealth and mobile health industries.” If this an accurate statement of the task force’s purpose, the parade not only has gone by, but it’s also three counties away. Yet going back in our files, this Editor notes that the FCC has vigorously fenced not only with the FDA, but also with HHS, NIH, NIST and Congress for its place in the Federal HIT regulatory firmament. With issues such as ‘net neutrality’, wireless bandwidth and rural broadband, the FCC has a heaping healthcare helping on its plate just in assuring national access and removing conflicts in frequency demands by devices. However, the task force is headed by Michele Ellison, lately the FCC’s top regulatory enforcer with, as The Hill notes, 6,000 actions under her belt. In Foggy Bottom, things are never what they seem. iHealthBeat
Edited from the HHS release. US Health & Human Services (HHS) Secretary Kathleen Sebelius and UK Secretary of State for Health Jeremy Hunt on Thursday 23 January signed a bi-lateral agreement for the use and sharing of health IT information and tools. The agreement strengthens efforts to cultivate and increase the use of health IT tools and information designed to help improve the quality and efficiency of the delivery of health care in both countries. The two Secretaries signed the agreement at the Annual Meeting of the HHS Office of the National Coordinator (ONC) for Health Information Technology. It concentrates on four key areas identified at the joint June 2013 summit:
- Sharing Quality Indicators
- Liberating Data and Putting It to Work
- Adopting Digital Health Record Systems
- Priming the Health IT Market
Collaboration efforts will be showcased at the Health Innovation Expo conference at Manchester Central 3-4 March (two weeks before HC2014) and the Health Datapalooza on 1-3 June in Washington, DC. A possible good sign for telehealth as there’s a great deal of mention of ‘preventive interventions’, ‘accessing and sharing data’ and the ‘health IT marketplace’.
Full memorandum of understanding text here. Also iHealthBeat.
19-20 March 2014, Manchester Central, Petersfield, UK
For over 30 years, HC has delivered thought leadership; informing and educating its audience on the how the latest innovations in technology support the increasing demands within healthcare. HC2014 will address all the current healthcare reforms with a number of themes referring to the call for paperless NHS by 2018. Key sessions will demonstrate technology to support Patient Engagement, Safer Hospitals and Integrated Care. Conference and exhibition presented by the BCS, The Chartered Institute for IT, in partnership with HIMSS. Conference keynoters include Tim Kelsey, NHS England; Andrea Sutcliffe, Care Quality Commission; Mike Pringle, Royal College of GPs; Kingsley Manning, HSCIC. Information and registration. Hat tip to reader Louise Sinclair. If there are TTA readers planning to attend, we are once again inviting you to contribute an article or a compilation of impressions. This can be filed within 72 hours of the close of event; alternatively, during or at day’s end/start. If you are interested, please email EIC Donna here (firstname.lastname@example.org). It is expected that you can be selective and interesting rather than comprehensive. You will be credited of course but expenses and article will not be covered.
HISTalk: “I’ve been at the conference for two days and it still doesn’t have a clear identity in my mind. Others told me the same thing – it’s unfocused and hard to describe, much like “mHealth” itself.” The anonymous editor of this hospital HIT-oriented blog scores the conference for lack of provider-oriented content and participants, being a ‘speed-dating’ event for companies and investors (the original governmental/NGO/non-profit focus utterly swamped by the commercial), and the event management (which is largely out of the organizers’ hands and in the site’s). Part of the confusion may well be the fact that mHealth is 1) exploding and 2) transitioning (‘m’ going the way of ‘e’ in Health). A second article underneath the main from an anonymous CIO criticizes many of the sessions for being mislabeled, the Executive Breakfast for being underserved–and Tuesday was an improvement over Monday. Food a major complaint!
You do have to wonder if the GSMA writer attended a different conference because he resolutely focuses on wireless and NGO/social organization mHealth frameworks. An interesting but limited perspective. And the article includes a major error: Paul Jacobs of Qualcomm did not deliver the opening keynote as originally listed, but Rick Valencia of Qualcomm Life. One Qualcomm as good as another? Commercial Models to the Forefront: Key trends at mHealth Summit 2013 (GSMA.com)
Sunday’s WIPJam (Wireless Industry Partnership) with 20+ speakers seems to have been the in place for the mobile developer crowd, with Mobile Development 101, mobile trends, 10 ways to fail in first-time app development and more. Seventeen of these presentations are available to view at a Dropbox link here.
Unlike the rampant data insecurity present in the state health insurance exchanges and the Federal HealthCare.gov, Texas is moving forward to secure data from providers within the state. The Texas Health Services Authority and the Health Information Trust Alliance (HITRUST) are developing and managing the Texas Covered Entity Privacy and Security Certification Program. Organizations must assess their compliance with privacy and security regulations, and if they do will receive a certification recommendation from HITRUST. According to iHealthBeat quoting a VP there, how this is implemented will have repercussions far beyond the state. A major goal, according to Health Data Management, is to reduce data breaches which are levied in Texas alone between $5,000 and $1.5 million–not including HHS. Also Modern Healthcare, HITRUST process page.
From the iHT2 Health IT Summit this Editor attended two weeks ago is this presentation by Jonathan Weiner, DrPH, Professor in the Department of Health Policy and Management, Director of the Center for Population Health IT (CPHIT), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. Telehealth is (or should be) implicit in the data feedback loop outlined in slide 3; in the population health assessment and performance loop on slide 5; the ‘digital health milieu’ on slide 9.
Harnessing EHRs and Health IT to Achieve Population Health Interview with Dr. Weiner
Canada’s federal government has stated that they have been thinking long and hard about extending digital health to more Canadians. In 2012, they commissioned and funded an independent organization, Canada Health Infoway (Inforoute Santé du Canada in the mandatory bilingual terminology) to study future healthcare needs, determine where digital health could make a difference and propose a strategic plan. After surveying 500 individual Canadians, clinicians, governments and health care administrators, national associations and vendors (a small number, it seems to this Editor), their report (PDF here) centers on five opportunities for action: (more…)
CIO has an excellent summary of how HIT is attempting to cope with the tidal wave of mHealth. Moving away from the ‘look up, receive alerts’ passive mode versus being able to enter data on that mobile device (whether BYOD or hospital issue) means having to focus on architecture, infrastructure and governance priorities (rather than one-offs), fitting mobile into workflows (field discovery of clinical needs), alignment of IT with line-of-business departments and figuring out how patient engagement really works plus how it fits into the previous (and it’s not the hype of what developers would like to see and sell.) Healthcare IT Struggles to Keep Up With Mobile Health Demands
29 September – 2 October 2013, Santa Clara (California) Convention Center
The 7th Annual Health 2.0 national conference will be held in the heart of Silicon Valley. It is 2 1/2 days and the ‘carefully curated lineup’ will feature the role of consumers, big data and health care marketplaces. The Health IT Startup Showcase is staged like ‘The Voice’, Tim Kelsey of NHS England is a speaker and the demo ‘bake-off’ Launch! is on Day 2, and Day 3 features Health 2.0 Around The World. Information, agenda, registration link.
ATA 2013’s final ‘industry executive session’, presented at the late hour when most attendees are daydreaming about a comfy chair and a solid drink, tackled one of the thornier underlying questions beleaguering health tech: return on investment (ROI). Providers want hard numbers, but even that definition is…indefinite. Is it data? Is it outcomes? Is it savings? Is it reduction in spending? For two systems or populations, it can be reducing 30-day same cause readmissions for one provider or improved outcomes in home care for another, and the results are not analogous nor even cause-and-effect. As Eric Wicklund from mHIMSS put it, “that’s the challenge, and it was the primary focus of this year’s ATA conference. The pilots are gone, the possibilities and proposals are old. It’s time to target the telemedicine and mHealth programs that are working and to explain why they are…” As GlobalMed’s Roger Downey less delicately put it, “It’s like pinning Jell-O to a wall”–but getting specific as to what should be done in the market helps. Not quite as blithe as the headline. ROI? To some of the industry’s top vendors, that’s just three letters.
Of course, EHR implementation continues to be the Rodney Dangerfield of health tech, with HITECH Act ‘Meaningful Use’ interoperability goals and patient platforms only spottily achieved despite years of generous past, present and future incentive payments. Yet one ATA presenter seriously advocated the addition of telehealth/telemedicine to MU standards, recommended that Health and Human Services become the authority and to add panels for Federal standards and policy in telemedicine as there are for health IT. Adding telehealth and telemedicine to the MU scramble will surely speed implementation ;-) (See above) Why not MU for telemedicine? (HealthcareITNews)