Privacy changes could limit data for comparative effectiveness

By Nick Taylor

- Last updated on GMT

Related tags: Clinical trial

Creation of large datasets for use in comparative effectiveness research and other fields could be limited by privacy modifications to the HITECH act, according to ACRO.

Proposed amendments to the act are intended to strengthen the privacy and security protection of health information. Association of Clinical Research Organizations (ACRO) is concerned the modifications to remuneration will discourage the creation of large, partially anonymised datasets.

Currently, legitimate researchers can acquire the use of such datasets through licensing, access fees or other payment arrangements. Proposed amendments to The Health Information Technology for Economic and Clinical Health Act​ (HITECH) could change this situation.

The amendments limit remuneration to “a reasonable cost-based fee to cover the cost to prepare and transmit the protected health information​”. Imposing this limitation would exclude remuneration for operating, capital and opportunity costs, according to ACRO.

Simply, covered entities will have little or no incentive to create, maintain, use and make available very large electronic data sets if their cost recovery is narrowly limited to “staff time”, for instance​”, wrote Douglas Peddicord, executive director of ACRO.

Restricting remuneration could reduce creation of limited datasets (LDS) for use in comparative effectiveness, outcomes and quality assessment. Peddicord detailed these concerns in a letter to Kathleen Sebelius, secretary of the US Department of Health and Human Services (HHS).

Data disclosure

Under the current wording of the Health Insurance Portability and Accountability Act (HIPAA) protected health information (PHI) can be used or disclosed for research in certain circumstances. This includes if the disclosure is authorised by the individual.

Disclosure without authorisation by the individual is allowed in five situations, for instance obtaining institutional review board (IRB) or Privacy Board waiver. Despite having a number of options available researchers believe HIPAA impedes health research, according to ACRO.

If the HHS provided stronger guidance and clear expectations regarding HIPAA to IRBs the situation could be improved, wrote Peddicord. This would give IRBs the confidence and knowledge to use their waiver powers correctly.

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