Tag Archives: mHealth

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading

FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches

FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software … Continue Reading

FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] … Continue Reading

FDA Announces a New Digital Health Innovation Plan

FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century … Continue Reading

FDA Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are … Continue Reading

Summary Report of European Commission’s mHealth Consultation Published

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation.  The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software … Continue Reading

FCC Holds mHealth Expo to Connect Innovators and Regulators

On December 6, 2013, the FCC held an mHealth Innovation Expo to showcase the innovative use of mobile communications devices to improve health care.  Innovators at the expo had the opportunity to showcase mobile health products and solutions and provide resources for mobile health pioneers and entrepreneurs.  The FCC and other federal agencies, including the … Continue Reading

Key Open Questions for FDA’s Upcoming Report on Regulation of Health IT

We’ve previously blogged about the “FDASIA Workgroup” and section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which directed FDA to issue a report to Congress by January of 2014 on the regulation of health technology.  This post covers some of the differing views on Health IT regulatory issues and open … Continue Reading

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of the … Continue Reading

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

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

Growth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory Questions

Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users’ lifestyles.  Jawbone’s UP can track sleep, movement, and diet, … 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

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 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