Our current Potpourri features Google’s dropping of its PHR, the AMA’s report on insurer claims paying, the role of health advocacy groups, employer’s intentions in regard to offering health coverage, drug approval in the US versus Europe and the use of a checklist to improve quality in the ICU.
The FDA issues a draft guidance on the use of clinical pharmacogenomics, in particular the gathering of relevant pharmacogenomic data in early drug development studies.
Another in our weekly series of health care nuggets, with this week’s Potpourri featuring Medicare beneficiaries and physician supply, the FDA’s position on certain device software, a wellness survey, the AMA’s stance on genetic testing, marketing of drugs, and an integrated disability and health care program.
The FDA’s 510(k) medical device approval process has been criticized for requiring too little data on potentially harmful devices. The FDA undertook a review of the process and has issued a description of initial steps it plans to take, which the industry seems to view as acceptable.
An incredibly useful paper has been issued by the mHealth Regulatory Coalition on issues surrounding potential FDA regulation of communications technology used for health-related purposes. The paper provides background and a discussion of the significant issues upon which the industry, patients and providers need guidance.
Happy New Year and a prosperous 2011 to all of you, a prosperity which undoubtedly will be aided by the insights from our Potpourris, which this week include physicians’ use of patient satisfaction data, drugs for children, Medicaid quality measures, health reform provisions taking effect in 2011 and the FDA’s rate of drug approval in 2010.
About this Blog
The Healthy Skeptic is a website about the health care system, and is written by Kevin Roche, who has many years of experience working in the health industry. Mr. Roche is available to assist health care companies through consulting arrangements through Roche Consulting, LLC and may be reached at [email protected].
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