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21st Century Cures bill passes House committee unchanged on privacy concerns

HIM-HIPAA Insider, June 1, 2015

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The 21st Century Cures Act, a new healthcare bill that would relax portions of HIPAA privacy laws to further medical research and penalize health IT vendors that fail to comply with interoperability standards, has passed through the full House Committee on Energy & Commerce.

The bill would inject billions of dollars into medical drug research and innovative treatments, accelerate the research process, and clear away regulatory hurdles on various levels. One provision of the bill, however, requires HHS to revise or clarify provisions of the HIPAA Privacy Rule in regard to use and disclosure of patients’ PHI for the purposes of research.

The Privacy Rule currently allows healthcare providers to use PHI without authorization for treatment, billing, and internal healthcare operations. Under the proposed law, however, those covered entities and their business associates would have the same unfettered access to those records to use in researching new drugs and treatments.

The bill would also impose penalties for vendors who engage in information blocking. The Wall Street Journal reports there is criticism at provisions that relax regulations on drug and device safety as well.

Proponents of the bill argue all these changes will remove barriers for patients to life-saving medical advancements and say PHI used in research would still be fully protected under HIPAA Privacy, Security and Breach Notification Rules. There’s also consideration of seeking one-time authorization from patients.

The bill passed through the health subcommittee May 14 and was unanimously approved by the full committee May 21. None of the amendments to the bill, however, address concerns about changes in privacy law. The full House is expected to take up the bill later this year.

This article originally appeared on HCPro’s HIPAA Update blog. Stay up to date on all things HIPAA by signing up for e-mail updates from this blog.

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