Margaret A. Hamburg, M.D, FDA Commissioner reported on FDA’s health information technology actions when she appeared before the Senate Committee on Health, Education, Labor and Pensions on March 13.
One action involves collaborating with others on health IT. FDA has been working in collaboration with the FCC and the HHS Office of the National Coordinator for Health IT and will soon publish on respective web sites, a report containing a proposed strategy and recommendations on an appropriate risk-based regulatory framework pertaining to health IT.
To do the report, FDA, FCC, and ONC convened a working group of external stakeholders and experts under the Office of the National Coordinator’s Health IT Policy Committee to provide input. Open meetings were held, documents and information made available to the public, and information was solicited from the public during every meeting via a public docket. In developing the report, the agencies took into account ONC’s Health IT Policy Committee’s recommendations.
Also, last September, FDA published the final guidance on mobile medical applications so that there would be clarity and predictability for manufacturers of mobile apps. The agency intends to apply its regulatory authorities to software applications intended for use on mobile devices that perform the same functions as traditional medical devices.
The agency is going to use discretion for the majority of mobile apps that pose low risk for consumers and FDA intends to focus regulatory oversight on the subset of mobile apps that are considered to be medical devices that would present risks to patients if the apps do not work as intended.
In another FDA matter, she told the Senators how the Drug Quality and Security Act (DQSA) outlines critical steps to build an electronic interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. DQSA is scheduled to be phased-in with new requirements over a ten year period and will include placing unique product identifiers on individual drug packages plus provide product and transaction information at each sale.
The new system will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain, and facilitate more efficient recalls of drug products.
In addition, FDA has developed public private partnerships to help advance regulatory science for devices. These partnerships include the Centers for Excellence at the University of Maryland and Georgetown University, the virtual Center of Excellence in Regulatory Science formed with the State of Arkansas, and the Medical Device Innovation Consortium formed as a a partnership between FDA. NIH. CMS, medical device companies, patient advocacy groups, and non-profit organizations.