Morgan Lewis

Health IT Resource Center

Key Members of the Resource Team

Related News

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

Related Events

Related Publications

09/25/13 FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications
Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
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FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices.
01/03/13 Increasing Scrutiny of Consumer Data Collection
Recent FTC and California Attorney General actions highlight the need to reassess privacy policies.
August 2013 FDA Efforts to Balance Health IT Innovation and Safety, LMG Life Sciences
The US FDA looks to adopt a flexible approach to mobile medical app and Health IT regulation that will both foster innovation and protect the public health. (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 FDA also has issued a draft guidance document applicable to mobile software applications intended for use on mobile platforms, including smart phones, tablet computers, and personal digital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

The Latest

On April 3, the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology jointly issued a report that sets forth a proposed strategy and recommendations for a risk-based regulatory framework for health information technology. Comments on the report will be accepted until July 7, 2014. Read a summary of the report here >