These days, mobile health (mHealth) seems to be everywhere. As the use of health text messaging, mobile phone apps, remote monitoring, and portable sensors has expanded, they have changed the way healthcare is being delivered in the U.S. and in Europe.
But with rapid change and innovation come questions, false starts, and regulatory uncertainties. Just like when drug and device companies (and FDA) struggled to come to terms with social media, they are now having difficulties dealing with the regulatory hurdles around developing mobile apps for patient use (see, for example, FDA's Latest "Guidance" About Mobile Apps Is Much Ado About Nothing).
Over in Europe, the Medical Device Directive (MDD) is playing catch-up with respect to mobile apps. And in the U.S., mHealth providers are trying to navigate FCC regulation of the radio spectrum, the impact of HIPAA and other privacy laws on data being transmitted, and FDA's role as gatekeeper to the market for mobile medical applications.
Fxconferences.com features two presentations that will shed light on this quickly developing field: Mobile Medical Apps for Europe: What You Need to Know from a Regulatory Point of View and mHealth Converges – The Impact of FCC, HIPAA/Privacy and FDA Challenges.
Also take a look at these past articles; it's amazing to see how far we've come in a short amount of time:
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