With its recent decision in ending ‘net neutrality’ as directed in the FCC‘s 2010 Open Internet Order, the (Washington) DC Circuit Court of Appeals has changed the playing field for mHealth. The FCC regulation treated internet service providers (ISPs) like telecommunications companies by enforcing telecom ‘common carriage’ requirements that prevented ISPs from blocking or discriminating against types or providers of internet traffic. The current situation is now a double-edged sword for the ISPs: on one edge, ISPs such as Verizon, Comcast or Charter won, because they now can charge fees to, slow down or demand revenue sharing of high-demand content... Continue Reading
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Medical apps largely missing medical expertise: study
...UK study in 2011 that examined 111 pain-related apps, with similar findings. As our readers know, in the US Happtique had taken on the role of a health app certifier through its Health App Certification Program (HACP), and presumably despite their internal changes that certifying process will continue and information will be accessible to the public. The FDA is still debating (and debating) app approval processes (along with the FCC, HHS…) while approving a few [TTA 22 Mar]. AAPM has also expressed interest in ‘gatekeeping’ for pain management apps. American Medical News/Amednews.com Hat tip to reader George Margelis of Australia... Continue Reading
Healthcare IT–New York’s Next Big Thing
...that are ‘pivoting’ (a polite term for retrenching) because their data, once generated, does not back their idea. Other matters needing resolution, and added by Mr. Loncar, are regulatory (FDA, FCC) and privacy standards. “HIPAA must be tackled sooner rather than later”–and it is not as difficult as many say. When queried by this Editor about the danger of patent trolls, it was felt by the panel that at this point, with companies of small size, they were unattractive since there was little in assets to go after. (However, after the conclusion of the presentation, an attorney in the audience... Continue Reading
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.... Continue Reading
FCC very quietly names Director of Health Care Initiatives (US)
With no official announcement, the US Federal Communications Commission (FCC) has selected Matthew Quinn from the National Institute of Standards and Technology (NIST) for its first-ever Director of Health Care Initiatives, as reported in FierceMobileHealthcare (via Mobihealthnews). His maiden appearance was at a recent Care Continuum Alliance Capitol Caucus in Washington, D.C. This contrasts with the relative fanfare back in December of the new position and its big scope–administering the Health Care Connect Fund, the health care part of the National Broadband Plan, developing spectrum policy for Medical Body Area Networks (MBANs) and other medical devices as well as expanding... Continue Reading
If not FDA to regulate mHealth, then who?
...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,... Continue Reading
Rock Health’s guide to FDA for the health tech entrepreneur (US)
...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... Continue Reading
‘Leading the charge in wireless health’–to where?
...and disparaging view of her colleagues’ (and users) motives (and perhaps some bad editing), it simply wasn’t there in the hearings. Based on reports extensively compiled here, it was exactly the opposite–acceptance. There was justified frustration, as who (FDA? ONC? FCC?) will be handling the tidal wave of mobile health reviews and approvals where needed for public health safety, and when this will be decided. There was eagerness to determine how it will be done, in resolving big issues (like excluding mobile phones per se from medical devices) and in expediting the process. Quotes like “When it comes to digital... Continue Reading
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... Continue Reading
What chefs are cooking in the kitchen: FCC adding $400 million to rural telemedicine
Something’s always cooking in the Federal Government kitchen…in this instance the chef is the FCC, and the dish being spiced is the Clinton-era rural broadband scheme for telemedicine. The Rural Healthcare Connect Fund of $400 million will be allocated to rural hospitals, clinics, mental health centers, local health departments and medical/dental schools to connect them with corresponding urban providers and networks, improving quality and immediacy of care. Presumably the money was found in the couch cushions as the debt ceiling is already reached…$400 million FCC fund to bolster rural telemedicine networks (FierceMobileHealthcare)... Continue Reading
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