Morgan Lewis

Health IT Resource Center

Key Members of the Resource Team

Health IT FAQs

Related Practices

Related News

05/22/13 FDA Shows Deft Touch With 1st Mobile App Enforcement, Law360
FDA & Healthcare associate Michele L. Buenafe is quoted.

Related Publications

May 2011 New FDA Rule May Affect Healthcare Facilities Using Customized Health IT Systems, published in AHLA Connections (c) 2011 American Health Lawyers Association
(pdf)
May/June 2011 FDA Issues Final Rule for Medical Device Data Systems, Classifying Certain Health IT Products, FDLI Update
(pdf)
07/28/11 New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions
01/03/13 Increasing Scrutiny of Consumer Data Collection
Recent FTC and California Attorney General actions highlight the need to reassess privacy policies.
02/15/11 New FDA Rule on Data Systems Has Implications for Device Manufacturers, Health IT Developers, and Healthcare Providers
May/June 2008 Computer and Software Devices: FDA Seeks Framework for Regulation, FDLI's Update
(pdf)
06/17/13 FDA Taking on Cybersecurity Risks for Medical Devices
FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices.
May 2009 FDA and Health IT—As Role of Health IT Gains New Significance, Regulators Will Be Keeping Watch, Health Law Analysis
(pdf)

Are You Ready to Market Your Health IT Product?

New and innovative health IT products, many of them created for consumer use, are hitting the market at rapid-fire pace—a phenomenon that, in turn, has prompted greater scrutiny by regulators and the birth of new rules governing such products.

Specifically, the Food and Drug Administration promulgated new regulations in 2011 to classify and regulate medical device data systems (MDDS)," defined as hardware or software products that transfer, store, convert formats, and display data from medical devices. FDA also has issued a draft guidance document applicable to mobile software applications intended for use on mobile platforms, including smart phones, tablet computers, and personal digital assistants. FDA recognizes that such products—smartphones that display radiological images or an app that acts as a medication reminder, for example—answer the demands of an increasingly consumer- and efficiency-driven healthcare industry but also carry greater potential for patient risk.

In addition, Section 618 of the Food and Drug Administration Safety and Innovation Act (enacted July 9, 2012) calls for the agency to work with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission to prepare a report on strategies and recommendations for the regulation of health IT in general by January 2014.

The Health IT Resource Center is both a basic roadmap to FDA's requirements and a resource for updates on the continuing evolution of health IT regulation. Questions or comments? Please contact the Morgan Lewis Health IT Regulatory Team at healthIT@morganlewis.com.

The Latest

See our summary of developments in the first half of 2013 related to FDA regulation of software and mobile medical apps.

Highlights cover:

  • Sales/consumer use of smartphones or tablets
  • Who is NOT a "medical device manufacturer"
  • Plans for narrow, risk-based regulation (comments deadline August 31)
  • Final guidance coming October 1, 2013
  • First mobile medical app enforcement action (posted on May 21, 2013)