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AMIA cites concerns about proposed HIPAA modifications
Date:9/28/2010

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Prohibition of Sale of PHI

Position: AMIA opposes a change in the current definition for Limited Data Sets (LDSs) from "not fully identifiable" protected health information (PHI) to "fully identifiable" PHI, which would prohibit the sale of LDSs, and provide little incentive for Covered Entities to create, maintain, use, and make available very large electronic data sets.

AMIA suggests modified language to new 164.508 (a)(4)(ii)(B), which would make an exception for research purposes, cost restrictions for PHI exchanged in the form of limited data sets. If cost restrictions related to 164.508 (a)(4)(ii)(B) are included in the Final Rule, AMIA urges the HHS to consider including all costs related to aggregating electronic PHI in general, or LDSs in particular, and not limiting costs to "staff time".

Research

Position: For research projects with both "conditioned" and "unconditioned" authorization requirements, AMIA supports the NPRM proposal for one compound authorization.

Related to the development of HIPAA authorizations that would permit future use and disclosure of PHI for research purposes, if an authorization form describes such future research activities or uses in sufficient detail to allow meaningful informed consent, AMIA suggests inclusion of a mechanism to allow an individual to revoke an "unspecified" authorization at any time.

To facilitate health research, currently viewed as impeded due to the enormous burdens related to HIPAA 'enforcement' placed on Internal Review Boards (IRBs), AMIA believes that HHS should provide strong guidance and clear expectations to IRBs regarding HIPAA, perhaps through the development of FAQs that illuminate IRB policies for reviewing and approving, or justification for not approving health information use for information-based research projects.

Restricting Information Based on Self-Payment

Position: AMIA opposes the NPRM sti
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Contact: Nancy Light
nlight@amia.org
301-657-5903
American Medical Informatics Association
Source:Eurekalert

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