FDA's Growing Role Regulating Health 2.0, Health IT

Many involved in the world of health IT know that federal regulation is part of the deal. Issues of health information privacy have been subject to an array of federal and state laws for decades. HIPAA, the Federal Privacy Act, laws governing Medicaid, Medicare, the Veterans Health Administration, funds used for the treatment of mental illness, sexually transmitted infections and on and on all have privacy provisions. There is a similar regulatory scheme for data security, again including HIPAA, the Gramm-Leach-Bliley Act and other laws.

More recently, Congress began authorizing HHS and its Office of the National Coordinator for Health IT to fund and regulate electronic prescribing standards, health IT standards, certification, "meaningful use", information exchange and other provisions found in the American Recovery and Reinvestment Act of 2009.

Regulation of Health 2.0?
What many do not know is that FDA likely will play an increasingly important role in regulating health IT. We're reminded of this most immediately by the recent announcement that FDA is holding a public meeting regarding the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." The official announcement appears in the Sept. 21, 2009, Federal Register.

This hearing, set for mid-November 2009, in Washington D.C., is intended to help guide FDA in making policy decisions on how the Internet and social media tools (e.g., blogs, microblogs, podcasts, social networking sites, online communications, video sharing, widgets, and wikis) can be used to promote FDA-regulated medical products -- including human and animal drugs and biologics, and medical devices -- in a truthful, non-misleading, and balanced manner.

Specific questions that will be addressed at the meeting include:

• For what online communications will manufacturers, packers or distributors be held accountable?
• How can manufacturers, packers and distributors fulfill regulatory requirements (e.g., fair balance) in their Internet and social network promotions?
• What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
• When is the use of links appropriate?

By Bruce Merlin Fried
October 2, 2009
Source: iHealthBeat