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 FDA also has issued a draft guidance document applicable to mobile software applications intended for use on mobile platforms, including smart phones, tablet computers, and personal digital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.
See our summary of developments in the first half of 2013 related to FDA regulation of software and mobile medical apps.
- 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)