Sunday, February 5, 2012

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BNA INSIGHTS: Proposed HITECH Act Data Privacy Rules: How Would They Impact Pharmaceutical Companies?

In a move meriting attention by the pharmaceutical industry, the Department of Health and Human Services (“HHS”) recently issued a notice of proposed rulemaking (“Proposal”) to implement certain of the health information privacy and security requirements of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. If adopted, the Proposal’s modifications would amend portions of the data privacy and security regulations promulgated by HHS pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)—generally referred to as the HIPAA Privacy and Security Rules. Although pharmaceutical companies are rarely governed by those regulations because they do not meet the definition of a HIPAA “covered entity,” the Proposal nevertheless has important implications for pharmaceutical company operations, particularly in the areas of marketing and research.

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