Bill

Bill > HR2549


US HR2549

US HR2549
To amend the HITECH Act with respect to accessing, sharing, and using health data for research purposes.


summary

Introduced
05/21/2015
In Committee
05/22/2015
Crossed Over
Passed
Dead
01/03/2017

Introduced Session

114th Congress

Bill Summary

To amend the HITECH Act with respect to accessing, sharing, and using health data for research purposes. This bill amends the HITECH Act to require the Department of Health and Human Services (HHS) to revise or clarify the privacy rule established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to allow the use and disclosure of protected health information for research purposes without the individual's authorization, approval from an Institutional Review Board or Privacy Board, or representations from the researcher regarding limited use of the information. These disclosures may only be made to entities subject to HIPAA for health care operations or to business associates that are complying with the privacy rule for health care operations or data aggregation. There is no limitation on payments for these disclosures. Currently, payment is limited to the cost to prepare and transmit the information. An individual's protected health information may be disclosed without the authorization or agreement of the individual for research related to a product or activity that is regulated by the Food and Drug Administration. A researcher is allowed remote access to protected health information if security and privacy safeguards are maintained and the researcher does not retain the information. An individual's authorization to use protected health information for future research is sufficient for a research purpose if the authorization reasonably describes the research and provides instruction to the individual on how to revoke the authorization.

AI Summary

This bill aims to update the HITECH Act, which is a law that promotes the adoption and meaningful use of health information technology, to make it easier to access, share, and use health data for research. Specifically, it directs the Department of Health and Human Services (HHS) to revise privacy rules, established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), to allow protected health information (PHI) to be used for research without requiring individual consent, approval from an Institutional Review Board or Privacy Board, or specific assurances from researchers about limited use. These disclosures would only be permitted to other entities covered by HIPAA for healthcare operations or to business associates who are complying with the privacy rules for healthcare operations or data aggregation, and there would be no limits on payments for these disclosures, unlike current restrictions that only allow payment for the cost of preparing and sending the information. The bill also allows PHI to be disclosed without authorization for research related to products regulated by the Food and Drug Administration (FDA), permits researchers remote access to PHI as long as security and privacy safeguards are maintained and the information is not retained, and clarifies that a single authorization from an individual for future research is sufficient if it reasonably describes the research and provides instructions on how to revoke it.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (1)

Last Action

Referred to the Subcommittee on Health. (on 05/22/2015)

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