2014: the year of reckoning for the ‘better mousetraps’

Or, the Incredible Immutability of the Gartner Hype Cycle

From Editor Donna, her take on the ‘mega-trend’ of 2014

This Editor expected that her ‘trends for next year’ article would be filled with Sensors, Wearables, Glasses, Smartwatches, 3D Printing, Tablets and Other Whiz-Bang Gizmos, with splashes of color from Continuing Crises like Healthcare.gov in the US, the NHS’ 3million lives plus ‘whither UK telecare’, various Corporate ‘Oops-ses’, IP/Patent Trolls and Assaults on Privacy. While these will continue to spread like storm debris on the beach, providing continuing fodder for your Editors (and The Gimlet Eye) to pick through, speculate and opine on, what in my view rises above–or is under it all–for 2014?

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech…

…diving into the Trough of Disillusionment in 2014. Crystallizing this certainty (more…)

23andMe as Rorschach test

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/12/rorschach1.jpg” thumb_width=”125″ /]Just like the good doctor’s ink blot, there’s a lot of ‘reading into’ the travails of genomic ‘spit test’ 23andMe. Blogger PF Anderson, the Emerging Technologies Librarian for the University of Michigan Health Sciences Libraries, has collected them in pithy quotes and citations. For your weekend or holiday exploration: Collecting Thoughts on the FDA vs. 23andMe

FDA tells 23andMe genomic test to stop marketing (US)

Quantified Selfers and the D3H (Digital Health Hypester Horde) are in a swivet. This past Friday, FDA slammed the door shut on the 23andMe Personal Genome Service (PGS) saliva test. This past summer, the company broadly marketed to US consumers, including a TV campaign [Charles Lowe, TTA 7 Aug]. The FDA cease-and-desist letter cites that 23andMe never provided requested data on their July and September 510(k) filings, which are now ‘considered withdrawn’, and cites that “after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.” The danger is that people will make medical decisions based on the testing information and that the results produced may be faulty. It appears from FierceHealthcare that the kit has actually been marketed for five years. According to MedCityNews, it is backed by Google Ventures (the CEO/co-founder is the estranged wife of Google head Sergey Brin), New Enterprise Associates, MPM Capital and the Moscow billionaire Yuri Milner. A private citizen is petitioning the White House to overrule the FDA (as if that extra-legal move would be possible, but who knows with the influence of the Googlesphere?) and states that the agency ‘grossly overstates the risks’ (also MedCityNews). As of 2 Dec there are 3,306 signatures of the 100,000 needed; one suspects this administration has bigger slices of uncooked turkey on its plate such as Obamacare and a kind-of-achieved 30 Nov deadline on Healthcare.gov, which is now clearly seen as just one problem.

The 23andMe website is still fully up and still selling kits.

Editor Donna sorts through the noise for possible reasons why:  (more…)

Telehealth Soapbox: Medical device tax finally under fire; implications many (US)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/09/gizmodo-the-top-10-rube-goldberg-machines-featured-on-film-rube-goldberg.jpg” thumb_width=”180″ /]A key part of the Rube Goldberg (or Heath Robinson)-esque funding of the Accountable Care Act (ACA, a/k/a Obamacare) is a punitive medical device tax of 2.3 percent levied on gross sales (not profits) of hip, knee, cardiac implants, many dental materials, diagnostics such as scanners, radiotherapy machines, catheters and more. Since it went into effect on 1 January, it has raised $1 billion according to the Medical Imaging & Technology Alliance, the Advanced Medical Technology Association and the Medical Device Manufacturers Association in July–for a program that does not start till 2014. According to The Hill, senior Senators Orrin Hatch, Barrasso and Hoeven are pushing for a repeal amendment to be attached to the stopgap spending bill. The reasons why the tax deserves to be tossed out on its ear are: (more…)

AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (US)

9-10 October 2013, Hyatt Dulles Hotel, Herndon VA

The Association for the Advancement of Medical Instrumentation (AAMI) and the US Food and Drug Administration (FDA) have organized a conference on improving the safety and effectiveness of medical technologies used in homes and other nonclinical settings, such as telehealth and mHealth. There are risks and challenges to consider as technology is placed in nonclinical environments, in the hands of individuals who are not medical professionals. There is an impressive roster of supporting international organizations, including the British Standards Institution (BSI), the Wireless-Life Sciences Alliance (WLSA), the Center for Aging Services Technologies (CAST) of LeadingAge, The Joint Commission and Continua Health Alliance. Information, agenda, registration. Hat tip to reader Rob Turpin of BSI Standards Limited.

FDA publishes medical device interoperability standards (US)

While FDA is still dithering about issuing draft guidance on mHealth, it looks like medical device manufacturers can break out the champs, because FDA has now recognized 25 standards on medical device interoperability and cybersecurity. According to Bakul Patel of the Center for Devices and Radiological Health at FDA, “Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can “plug and play.” It’s an alphabet soup of industry standard abbreviations–IEEE, ANSI, AAMI, ISO, IEC and ASTM–and it’s purely voluntary, but various groups such as Continua and AAMI (Association for the Advancement of Medical Instrumentation) have praised this ‘first step’, and being published, it is now open for comment.

According to the Continua LinkedIn group announcement from Executive Director Chuck Parker, the 25 standards can be grouped into three categories:

  1. Risk management standards for a connected and networked environment
  2. Interoperability standards that establish nomenclature, frameworks and medical device specific communications and including system and software lifecycle processes
  3. Cyber security standards from the industrial control area most relevant to medical devices.

As the FierceHealthIT article cited, interoperability failure is a top 10 health technology hazard according to the ECRI Institute.  One can hope the new standards can be applied retroactively to current devices which are not being patched and updated because manufacturers fear running afoul of FDA clearance regulations and counter that ‘discouragement’. [TTA 8 AugAAMI News, Federal Register 6 August, FDA Voice (blog article by Bakul Patel)

FDA’s discouraging role in medical device security

According to a Wall Street Journal report (unfortunately firewalled), hospitals are pointing a very long finger at medical device manufacturers for not updating software and leaving devices open to breaches. Yet the manufacturers readily cite FDA’s most recent guidance as prohibiting software updates and security patches without resubmitting their devices for approval–something a spokesperson for the FDA denies as long as the update is for cybersecurity only. If the draft guidance issued in June is actually finalized, it will go the distance in helping manufacturers and hospitals. Hospitals Say Device Manufacturers Resist Boosting Cybersecurity (iHealthBeat)

The ‘Wild West’ of 40,000 mobile apps

Following up on our 11 June article that took a stern, fingerwagging view of these 40,000 unvetted apps out there on the prairie, MedCityNews looks at them and finds good news. Healthy lifestyle helper apps plus a health coach can produce positive results–and we’ve covered those like AliveCor and WellDoc which turn a smartphone into a medical device and are regulated by the FDA. The problem remains that there’s no vetting of apps of either type to confirm for the user that they are effective. Happtique is still cited as a app curator for consumers and doctors, when by all reports they have changed direction [TTA 17 May]. 40,000 health-related apps and no easy way to know which ones work

And while we are on the subject of FDA, now they are dealing with the strong possibility of cyberattacks on the data and systems of the very medical devices they are regulating. In a 13 June communication to manufacturers and providers, “Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches”–the introduction of malware or unauthorized access to configuration settings–made worse by internet, mobile access and the infamous cloud. Government Health IT

FDA regulation of mobile health: a study in ambiguity

The signs are not good when FDA continues to delay on issuing its draft guidance on mHealth devices (now tagged for the close of FY 2013), yet sends a notice to India’s Biosense Technologies Pvt Ltd, developer of the uChek Urine analyzer app, that it immediately needs to seek 510(k) Class II clearance. Biosense claims Class I clearance; FDA claims that it has no record. Letters fly, yet the app remains in the iPhone AppStore. How can there be a crackdown on mobile health apps, as FierceMobileHealthcare’s Greg Slabodkin projects, when developers legitimately say there’s no rules of the road? Magic 8 Ball says: ‘In The Fog’.  Also Mobihealthnews.

Previously in TTA: FDA regulating medical apps–or not? The Hearings. If not FDA to regulate mHealth, then who? An ‘Office of mHealth’ a solution for FDA gridlock?

An ‘Office of mHealth’ a solution for FDA gridlock? (US)

The ‘FDA Office of mHealth‘ bill (H.R. 6626) as sponsored by Mike Honda, Silicon Valley’s House Representative (California 17th District), which expired with last year’s Congress [TTA 18 Dec] will be revived with revisions, according to MedCityNews. (Rep. Honda will be keynoting on the second day of MedCityNews’ ENGAGE conference in Washington D.C. in June.) Formerly dubbed HIMTA (Healthcare Innovation and Marketplace Technologies Act) will now include how that office will work with the alphabet soup of other agencies: FCC, HHS, ONC, FTC. It struck this Editor in December–and later [TTA 28 Mar]–that this bill does not go far enough. In its good intentions to speed mHealth approvals by creating a framework plus monetary incentives, it is not powerful or independent enough to slice through or bypass various turfs.  What would be revolutionary is simplification. Why not an independent unit that draws from FDA, FCC and HHS, but has priority and license to cut through red tape? But that would require major giving up of ground–and with this Federal Government, that ain’t gonna happen. Add to it that the most innovative work–and usage– is being done at DOD (DARPA, T2) and the VA, and the alphabet soup becomes goulash.  Wall Street Journal’s Venture Capital Dispatch

If not FDA to regulate mHealth, then who?

For those looking for alternatives to FDA approval of  mobile health or medical apps, some organizations have been tossed into the Suggestion Box. It’s a veritable alphabet soup of abbreviations, starting with ONC (Office of the National Coordinator for Health Information Technology). There’s the private sector review entity initially created for EHR certification with the formation of CCHIT (Certification Commission for Healthcare Information Technology, part of HHS) or what CCHIT has now become, a private/federally monitored model. There’s also the FTC (Federal Trade Commission) which pulled an acne treatment app of the market, and the ever-popular FCC (Federal Communications Commission) which has been searching for a Director of Health Care Initiatives and after all has millions to dole out in the Health Care Connect Fund. Neil Versel’s latest over at Mobihealthnews focuses in on this (omitting the FCC), considers the suggestion by Thomas Santo, MD in a recent column at KevinMD that medical industry associations (AMA–American Medical Association, ACP–American College of Physicians, etc.) should also be involved with health tech tools, to the extent of a rating system or even endorsement–and argues against it. (This excludes Happtique’s certification program standards/performance requirements.) But since both FDA and the FCC are involved, now separately, in most things mHealthy, and at least one proposed bill (HIMTA) would create an FDA Office of Mobile Health, why not have a joint office as a single point of contact? FDA regs would remain the same, but the review would encompass both medical effectiveness and wireless issues.

Rock Health’s guide to FDA for the health tech entrepreneur (US)

In 26 slides, Rock Health has neatly summarized for those unfamiliar with the FDA approval thickets (99% of us) on what is a regulated health tech product and is not. Instead of a MEGO (my eyes glaze over) experience (familiar to all those who’ve sledded through the FDA website), there are simple examples in how to determine what class your device falls into (I, II, III) and what you need to do to gain approval. It also clearly defines the substantial difference between 510(k) premarket submission and the far more complicated PMA premarket approval–and the fact that after approval, FDA will forever be in your life. It also notes that other approvals such as FCC may be required and many other tips on how to make the process easier and less garment-rending for your organization. Features comments from Chris Bergstrom of WellDoc and Geoff Clapp, who co-founded Health Hero which is now Bosch Health Buddy. SlideShare link

FDA regulating medical apps–or not? The Hearings. (US)

Much coverage of this past Tuesday-Thursday’s US House of Representatives Energy and Commerce Committee hearings on how the Food and Drug Administration (FDA) should be regulating developing mobile health technologies.  Some key issues are if the 2.3 percent Obamacare medical device tax will apply to apps (after chilling development on surgical devices–see day 1 hearings), whether FDA will ever get around to publishing a final guidance (end of year), will FDA consider smartphones medical devices (no) and if FDA should share some of the responsibility with–or give it over entirely to–the Office of the National Coordinator for Health Information (ONC) under Health and Human Services (HHS). Can FDA even keep up at this stage? (it takes them about three months on average review) and How much will regulation add to the price? are major questions. The representatives have heard from numerous leaders in the field: Tuesday, Happtique’s CEO Ben Chodor and the mHealth Regulatory Coalition’s Bradley Merrill Thompson; Wednesday, West Wireless Institute’s chief medical officer Joseph Smith; Thursday, Dr. Farzad Mostashari, National Coordinator, Health Information Technology, HHS and Ms. Christy Foreman of FDA. Mobihealthnews’ Brian Dolan live blogged from the hearings; there are also testimony statements. From these reports, the hearings have decided exactly nothing and revealed little about FDA’s inaction, but at least the issues have received some fresh air from those in the industry.

An overview of the articles/blogs to date.  Updated 23 March  (more…)

FDA regulating medical apps–or not? (US)

The long-drawn out drama on the FDA’s endlessly pending (July 2011) final regulations on the approval procedure of mobile health apps seems to be coming to a crescendo with next week’s US House of Representatives Energy and Commerce Committee hearings. There are missed deadlines, unanswered questions, reports due, an apparent repositioning of mobile apps as ‘health IT’, the involvement of an alphabet soup of agencies–Health and Human Services (HHS), the Federal Communications Commission (FCC) and, most importantly the Office of the National Coordinator for Health Information (ONC) under HHS, which seems to be breaking away and asserting control in the FDA vacuum. Cheering on ONC for dominance are health IT companies such as McKesson and perhaps some members of the Committee. This apparent lassitude on FDA’s part is certainly odd, as according to Mobihealthnews, the FDA has already approved 75 mobile medical apps. Brian Dolan over there has done fine work on sorting out this ‘who’s on first?‘–and why–situation in two articles, Republicans, EHR vendors want ONC to take over medical app regulation (14 Mar) and Congress asks FDA if “actual use” is factor in medical app regulation (6 Mar).

Related TTA: The mHealth road map, as drawn by the FCC and Adding another chef to the government regulation kitchen