Regulatory & Risk Management

Latest Headlines

Latest Headlines

Why it's time to start building the mobile healthcare roadmap

The increasing use of mobile devices and the growing number of aging adults requiring medical treatment are compelling reasons to start constructing the mHealth roadmap and move past the planning and...

JAMA paper: mHealth apps need more review, assessment

The proliferation and increasing use of mobile healthcare apps requires an unbiased review and certification process, argues a paper published Monday in the Journal of the American Medical...

It's time for the FDA to lead mHealth app regulatory strategy

The discussion and increasing debate of how to regulate, review, accredit and assess mHealthcare applications is getting louder, as software tools boast greater and more innovative capabilities...

Lawmakers want update on FDA mobile medical app regulation efforts

Six U.S. senators are asking the U.S. Food and Drug Administration for greater transparency and clarification regarding regulatory review of mobile medical applications and want specific answers on a wide range of issues from rulemaking and establishment of standards to Congressional oversight.

Brookings: Reimbursement issues, murky regs top mHealth challenges

The top challenge facing mobile health technology innovation and adoption in the U.S. is the lack of federal health agency and healthcare payer reimbursement, according to a new report from the Center for Technology Innovation at the Brookings Institution.

Samsung Galaxy heart-rate sensor ignites regulatory review

Government health officials in South Korea want to take a closer look at the heart-rate sensor built into Samsung's impending Galaxy S5, but the regulatory review likely won't impact the smartphone's scheduled debut on April 11.

Debate on mobile app regulatory oversight heats up

The mHealth Regulatory Coalition says a proposed law to eliminate oversight by the U.S. Food and Drug Administration  on mobile healthcare software poses serious risks to patients and that Congress must play a key role in ensuring FDA guidance on mobile applications.

Industry group voices 'extreme' concern with PROTECT Act

Opposition to the PROTECT Act continues to mount--this time, in the form of a letter signed by 12 health organizations. In a Feb. 14 letter to Senator Tom Harkin (D-Iowa), Chairman of the Senate...

Senators throw down mHealth gauntlet

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) took their legislative fight to limit the FDA's authority on mHealth to the American people in a Feb. 15 opinion piece on the editorial...

HIMSS14 mHealth symposium gets an early start

Next week, the Health Information and Management Systems Society (HIMSS) annual conference is being held in Orlando, Fla. If you can get there early, HIMSS14 has added a pre-conference mHealth...