Beyond HIPAA: A Proposed Self-Policing Framework for Digital Health Products
As digital health products proliferate, entities that fall outside HIPAA regulation are collecting vast amounts of biometric information.
As digital health products proliferate, entities that fall outside HIPAA regulation are collecting vast amounts of biometric information.
On September 22, the U.S. Food and Drug Administration announced the establishment of a new initiative to regulate digital health products.
In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information. The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection […]
By Rachel Sachs Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here […]
By Rachel Sachs In recent days, it seems like the din of voices arguing that the FDA should approve pharmaceuticals more speedily and on less evidence has grown louder. It is a central theme of the 21st Century Cures Act, which the House may vote on today and which I seemingly will never finish blogging […]
By Robert Field What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.” Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical […]
Aaron S. Kesselheim, M.D., J.D., M.P.H. [Twitter: @akesselheim], is an Associate Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). Within the Division, Aaron leads the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research], an […]
By Rachel Sachs The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. […]
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