Events
Duane Morris Attorneys Lisa Clark, Ken Keane and Michael Swit to Explore "mHealth Converges—The Impact of FCC, HIPAA/Privacy and FDA Challenges"
May 21, 2013 | Audioconference
Duane Morris attorneys Lisa Clark, Ken Keane and Michael Swit will examine "mHealth Converges—The Impact of FCC, HIPAA/Privacy and FDA Challenges" in a FX Conferences audioconference on Tuesday, May 21, 2013.
For those involved in developing and using mHealth applications and related devices, it is essential to understand how three major legal areas converge to influence the future of the mHealth industry—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.
Healthcare is increasingly delivered through wireless technology. Hospitals and other providers rely on it to create health information exchanges to create an architecture for the use, disclosure, transmission and storage of personal health information. These exchanges are built around electronic health records and permit the exchange of information among providers and patient access pursuant to federal law and regulations.
The use of wireless medical technology raises a number of privacy and security issues under the Health Insurance Portability and Accountability Act (HIPAA), which imposes privacy and security standards for protected health information. In addition, other federal and state laws impose stricter privacy and security standards for sensitive information relating to substance abuse, mental health, HIV/AIDS, reproductive health, genetic health and minors. Other non-healthcare-specific agencies and entities have also issued guidance or taken action with respect to the privacy of personal data transmitted by mobile means, including the Federal Trade Commission and the California Office of the Attorney General.
Many entities that engage in the use, disclosure, transmission and storage of electronic data believe that merely encrypting personal health information satisfies HIPAA and other requirements. While encryption goes a long way to protecting this information, the laws, regulations and guidance cited above impose additional requirements, including with respect to transparency and the use of personal data for advertising. Another critical issue is the segregation of sensitive information.
Companies developing mHealth applications must not only satisfy the requirements of the FCC and privacy laws primarily applicable under HIPAA, but also are confronted with the potential for complying with myriad requirements for the FDA relative to medical devices. While the FDA issued a draft guidance in July 2011 on its plans to regulate what it called "mobile medical applications," uncertainty remains rampant in the mHealth community as to whether particular apps are medical devices, and, if so, how the FDA will regulate those apps. This audio conference updates listeners on FDA's handling of mobile medical apps, including a review of recent testimony before Congress and its potential for the future of the FDA's mHealth regulatory regime.
To learn more, or to register, please visit the FX Conferences website.
