Archives: Medical Information Technology

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FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

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  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for … Continue Reading

US Information Security and Privacy Board Expresses Concerns about Management of Cybersecurity in Wireless Medical Devices

The US Information Security and Privacy Board (ISPAB) voiced concerns over potential harms resulting from a lack of controlled management of cybersecurity in wireless medical devices in response to FDA’s previously reported draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”  ISPAB operates under the National Institute of Standards and Technology … Continue Reading

Coalition Seeks to Delay Mobile Medical Apps Guidance

This July will mark the two-year anniversary of FDA releasing its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  Finalizing the guidance document is listed as an “A list” item on the Center for Devices and Radiological Health’s proposed guidance development for Fiscal Year 2013, and … Continue Reading

DoD to Consider Purchase of a New Health Information Technology System

On May 21, 2013, Defense Secretary Chuck Hagel stated that the Department of Defense (“DoD”) will carry out a full and open competition to acquire a new health IT system to achieve electronic health record (“EHR”) modernization and integration with the electronic health records managed by the Department of Veterans Affairs.  Based on Mr. Hagel’s … Continue Reading

FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

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 … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, 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) … Continue Reading

FDA Takes First Public Mobile App Enforcement Action

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.  Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading

EU Regulation on Electronic Instructions for Use of Medical Devices

Commission Regulation (EU) 207/2012 on electronic instructions for use of medical devices (the Regulation) came into force in the EU last month.  The Regulation allows manufacturers of certain types of medical devices and accessories to replace paper form instructions of use with an electronic substitute.  It aims to reduce environmental burden and improve the competitiveness … Continue Reading

FTC Releases New Guidance For Online Advertising Disclosures

Editor’s Note: This post originally appeared on our sister blogs, InsideTechMedia and Inside Privacy.   This FTC guidance will be of interest to device manufacturers, since the  FTC regulates advertising of non-restricted devices, and FDA is continuing to consider its regulatory policies for use of the internet and social media.  We note that FDA may … Continue Reading

Congress to Hold Hearings on FDA Regulation of Mobile Medical Apps and Impact on Innovation

On March 19, 20 and 21, 2013, the Energy and Commerce Committee of the U.S. House of Representatives will hold a series of three hearings on “Health Information Technology to Explore Potential Regulations and Taxes on Smartphones, Tablets, and Mobile Apps.” The hearings will take place in three different Energy and Commerce subcommittees and will … Continue Reading

Congress Shows Continued Interest In Mobile Medical Apps

Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of a “device.”  On March 1, 2013, six Republican members of the House Committee on Energy and Commerce sent a letter to … Continue Reading

Wireless Medical Device Law and Regulation Takes Center Stage at FCC, FDA, and Congress

Wireless medical devices stand at an innovative crossroad between health care, communications, and technology law and regulation. Many of the health and safety aspects of such devices are regulated by the Food & Drug Administration (FDA) and these devices use electromagnetic spectrum regulated by the Federal Communications Commission (FCC).  Lately, regulators at FDA and FCC … Continue Reading

FCC Considers Relocating Spectrum for Wireless Medical Devices in Repacking of Broadcaster Spectrum

The Federal Communications Commission sought comment, in connection with the incentive auction and repacking process reported in previous posts on InsideTechMedia, 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 comments … Continue Reading

FCC Begins Implementing mHealth Task Force Recommendations

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 … Continue Reading

ABA Section of Science & Technology Law Creates New Medical Devices Committee

The medical devices industry is a global industry at the forefront of medical technology and innovation.  And the ABA’s Section of Science & Technology Law (SciTech) explores emerging issues at the intersection of law, science, and technology.  This fall, SciTech launched a new medical devices committee to advance public understanding and shape the development of law and … Continue Reading

Unique Device Identifier Rule Moves Forward as Comment Period Comes to Close

In July, FDA issued a much-anticipated proposed rule to implement a unique device identifier (UDI) system (for a summary of the proposed rule see our earlier Advisory).  As the period for public comment on the proposed rule comes to a close on November 7, the comments provide insight into aspects of the rule that FDA … Continue Reading

Mobile Medical Apps: What Will Future FDA Regulation Look Like?

Over the next year, stakeholders may see several important developments related to FDA’s regulation of mobile health (also known as “mHealth”) devices, especially in the rapidly developing area of mobile medical apps. The universe of mobile medical applications (or “apps”) continues to grow rapidly. According to a recent Washington Post article, MobiHealthNews, an app-developer trade … Continue Reading