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 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