Picture murky: 23andMe and the FDA

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.

  • Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
  • Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.

Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge

Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)

FDA finally issues proposed rule simplifying medical device classification

The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.)  In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).  

As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure.  (more…)

Short, ‘springy’ takes for Friday

IBM Watson crunches the genomics for glioblastoma. A clinical trial at seven locations is being developed in partnership with the NY Genome Center to identify potential treatment options for the most common type of brain tumor–one where diagnosis and treatment time is of the essence.  iHealthBeat, Modern Healthcare….Also in NY, Montefiore Medical Center in The Bronx is evaluating several mobile initiatives including a current pilot for texts/care management to support diabetic teenagers, as well as evaluating interacting with diabetics on fitness and  biosensor monitoring. FierceMobileHealthcare….Yecco’s social media platform for families caring for older adults [TTA 13 Mar] adds insurance. Allianz Global Assistance UK announced Yecco Home Care insurance, providing up to six weeks of assistance at home following an accident, injury or hospitalization. Release….Six US Senators seek clarification on FDA mobile health regulations. The letter to FDA Commissioner Margaret Hamburg inquired on FDA plans and asked if legislative assistance might be required. The FDA/ONC-HIT framework report originally due in January now has a deadline of 31 March. iHealthBeat. The Hill ‘Healthwatch’….The Samsung Galaxy S5 won’t be considered a medical device by South Korea’s Ministry of Food and Drug Safety. According to Engadget, it was the heart-rate sensor that subjected it to stricter regulations under current South Korean laws. Oy….And it took a while, but finally the Tunstall Americas management page lists new CEO Casey Pittock at the top! (No release yet though.)

A very Appy week!

Although my fellow editor Chrys has done a great job of covering the Ofcom-sponsored report on attitudes and behaviours of apps users, and The Boss (aka Donna) has highlighted the HIMSS Analytics Mobile Study as well as covering the opposition to the PROTECT legislation, identifying a tax issue that might just be behind it all, there is still more to report on the apps front this week.

Beginning with that PROTECT legislation, the same Brad Thompson that Donna quotes also writes in Mobihealthnews of the recommendations of the FDASIA committee on how the FDA can improve the regulation of mobile health. The overall recommendation is that the “FDA needs to do a better job at (more…)

The PROTECT Act for HIT doesn’t: mHealth Coalition

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

FCC sharply elbows up to the mHealth regulatory table

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 HHSNIH, 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

Is *less* regulation the answer for mHealth? (US)

What if the solution to the mHealth/digital health logjam of approvals at the US Food and Drug Administration (FDA) is to take clinical and health software completely out of their approval purview–and hand it to the National Institute of Standards and Technology (NIST), which is not a regulatory body but a standards-development organization. That is the solution proposed by the PROTECT Act of 2014 (Preventing Regulatory Overreach to Enhance Care Technology), proposed by Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska). It’s put some of the better known organizations into a swivet, along with high profile attorney and mHealth legal expert Bradley Merrill Thompson with Epstein, Becker & Green. Possibly little to no regulation would be applied to EMRs, clinical support software and wearables/fitness apps–which is promptly being conflated by the usual suspects to heavy-duty equipment such as CT scanners.  FDA also finalized its guidance last September on telehealth and telemedicine applications, which this would render irrelevant. The Washington betting is that this Senate bill will go exactly nowhere, but it’s indicative of the jockeying for position this Editor is seeing within the present government and now with advocates/lobbyists [TTA 13 Feb]. MedCityNews, FierceMobileHealthcare

The CES of Health (Friday)

Rounding up the 10 Ring Vegas Circus-Circus, it’s time for ‘best and worst lists’: hopping with the Kiwi tracker, no one’s kind to Mother, in the kitchen with 3D printers and what may be up with Google, FDA and contact lenses.

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/01/02-itoi-620×400.jpg” thumb_width=”150″ /]ZDNet rounds up its Friday coverage with a Best of CES selection. It’s always interesting to get the broader non-healthcare techie view of ‘what’s hot’–they spotted fitness bands early when even diehard QSers were skeptical– and to then see if their picks make it into the broader market. Their health tech picks are the Mimo Baby onesie + detachable turtle monitor from Rest Devices (sure to be a hit at your next baby shower; TTA 10 Sept], movement profiler Notch(see Thursday; it also made The Guardian’s roundup), MakerBot’s home 3D Replicator Mini (Wednesday) and the Epson Moverio BT200 digital content projection smart glasses  (in-market March, @ $699.99 a bargain for what use?). Au contraire, see 11 born-to-fail worst gadgets which includes being mean to Sen.se’s Mother and, in worst design, an iPad video ‘periscope’ from iTOi which looked like it was stolen off the set of the 1956 space opera Forbidden Planet. For today’s market, it definitely could have used a steampunk vibe to carry off its ‘Blue Blazes’ design.

Yet one of their writers gives Mother, a/k/a the “M2M Mollycoddle”, “part-Russian doll and part-Doctor Who monster”, a more thoughtful once-over. (more…)

The CES of Health preview

International CES in Las Vegas will be the annual ten-ring circus it always is, but this year even the tech watchers are concentrating on health. There appears to be no blockbuster consumer electronics debuts this year, so what you will see in the rinse-and-repeat cycle are the connected categories of Wearables and The Internet of Things. Basically everything will be connected, automated…and gathering lots of data on you (what ZDNet’s Jason Hiner in his CES preview article has dubbed Contextual Computing, and he likes it). Lisa Suennen of Psilos Group, writing in MedCityNews, coins her own slightly dismissive term, ‘The Internet of Wearable Things’, and makes the entirely sensible point that sensing your fitness is one thing, doing something about it another. But the critical health app that soars over her goal posts is the Surf Life Saving WA Twitter account. If you’re in Western Australia and hitting the water, you want to know where the sharks are. This gives it to you. This Editor also sees that Samsung received FDA 510(k) approval for their heavily hyped S Health app built into the US-released Galaxy S4 smartphone. While the UK enjoyed third party device connectivity back to the S3, the US version of S Health, according to Mobihealthnews, only connected to three unreleased Samsung peripherals and relied on manual entries. This undoubtedly will change–expect there to be buzz about where Samsung will now take this at CES. And there’s always hay to be made with sleep analysis tracking–high-end multi-sensor fitness watch Basis Science has now added advanced sleep tracking to its BodyIQ analysis of running, walking and biking, as well as upgrading its looks (VentureBeat).

Certainly more to come out of CES and conferences within CES this coming week!

mHealth Summit 2013: Verizon’s role in the HIT ecosystem

Peter Tippett, MD, PhD Talks Verizon’s Role in the Health IT Ecosystem

Lois Drapin, Founder & CEO of The Drapin Group, in the third of her post 2013 mHealth Summit insights, speaks with CMO and VP of Verizon Enterprise Solutions, Peter Tippett, MD, PhD to share his insights on expanding Verizon’s role in the health IT ecosystem during the 2013 mHealth Summit. This article is courtesy of HIT Consultant.

I was happy to hear that Peter Tippett, MD, PhD, Chief Medical Officer and Vice President of Verizon Enterprise Solutions put aside thirty minutes for an interview with me at the mHealth Summit. I arrived at the large Verizon booth and was immediately greeted by one of my favorite women in health technology, Nancy M. Green, Managing Principal of Healthcare Practice at Verizon Enterprise Solutions. Disruptive Women in Health Care, a group founded by Robin Strongin, just announced their list of Disruptive Women to Watch in 2014 and Nancy is on that list. Congrats goes out to Nancy… and to Dr. Tippett for having one of these top women on his team. We like that.

I always ask people to share a little about themselves before we talk business. (more…)

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=”https://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=”https://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)