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HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Proposed Changes to the HIPAA Security Rule Will Have a Significant Impact on the Health Care Sector

A few days ago, the U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights, issued the proposed rule HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health...more

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