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FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year.

Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for regulating products within these Health IT categories.  FDA has stated that it intends to finalize the mobile medical apps draft guidance by the end of this fiscal year, and the agency has indicated that it intends to develop guidance regarding its regulation of clinical decision support software.

Track two is an assignment from Congress.  Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to issue a report to Congress by January of 2014 setting forth a “risk-based regulatory framework pertaining to health information technology, including mobile medical applications.” Section 618 also directed FDA to create a diverse working group of Health IT experts to assist it in this task.  That group held its final meeting last month, discussing a set of draft recommendations for regulation of Health IT.  The group will provide a final set of recommendations to FDA in September.  FDA will review the recommendations, along with public comments, when drafting its report to Congress.
Continue Reading FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device hacking, researchers have demonstrated the ability to remotely exploit devices such as implanted defibrillators and insulin pumps.

Addressing such threats, FDA has issued a draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”  The draft guidance is intended to make “recommendations to consider and document in FDA medical  device premarket submissions to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised.”…
Continue Reading FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) about its implications.

Commentators observed that the letter appeared to be intended, in large part, as an educational tool for industry.  As such, it’s appropriate to ask:  what lessons should industry draw?  Although single enforcement actions do not always serve as reliable predictors of future actions, the letter offers a handful of key takeaways:…
Continue Reading Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

The Federal Communications Commission sought comment, in connection with the incentive auction and repacking process reported in previous posts, on whether to relocate wireless medical telemetry service (“WMTS”) users from the 608-614 MHz spectrum band, known as Channel 37, or allow unlicensed devices to coexist with WMTS on Channel 37.  The proposal elicited…

In response to recommendations by the mHealth Task Force, the Federal Communications Commission has launched a new website to serve as a central repository for the FCC’s health care-related work and is searching for a new position to coordinate the agency’s health care technology-related initiatives.   Chairman Genachowski convened the FCC’s first mHealth Summit earlier this year to discuss the “promise of mobile devices to improve health care and lower costs. “   Participants in the summit formed an independent mHealth Task Force, which made a number of policy recommendations to the FCC, including the the appointment of a Director of Health Care Initiatives.  The Commission is now seeking to fill that position, which it says is an important step in the FCC’s ongoing mission to expand access to health care applications through wired and wireless broadband.   The mHealth Task Force report also recommended that the Commission comprehensively reform and modernize the Rural Health Care Program.

According to the FCC, the Director of Health Care Initiatives will spearhead the following health-related initiatives for the FCC:…

Continue Reading FCC Begins Implementing mHealth Task Force Recommendations

Federal Communications Commission (FCC) Chairman Julius Genachowski announced this week that he expects the FCC to release two orders on mobile healthcare technologies (mHealth) by the end of the year.  This announcement relates to the release this week of a report by the mHealth Task Force that made a number of recommendations with respect to ways that federal agencies and industry players can advance “mobile health, wireless health, and e‐Care technologies that improve patient care and the efficiency of healthcare delivery.
Continue Reading mHealth Moving Forward