Research group concerned new HIPAA regs could hinder clinical trials

The new HIPAA privacy and security regulations set to take effect next month may hinder clinical trials as researchers adapt to tighter restrictions on the use of patient data, the head of a key industry association says.

The rules, as called for in the American Recovery and Reinvestment Act of 2009, "go well beyond the privacy rules established by HIPAA in 1996 and constitute a de facto transition to HIPAA 2," Doug Peddicord, executive director of the Association of Clinical Research Organizations, says, according to eCliniqua. Peddicord notes that it took several years for healthcare providers to adapt to the first set of regulations, which took effect in 2003 and 2005 following transition periods of two years. This time, covered entities and their business associates have a much shorter timeline to adjust, as the new, statutory restrictions mostly are effective Feb. 17, one year after the passage of ARRA. New requirements on breach notifications have been in force since Sept. 23.

Peddicord says that enforcement agencies--which now may include states and the Federal Trade Commission in addition to HHS--could interpret the new rules as prohibiting covered entities from receiving payment for building databases with "anonymized" patient information. Without a financial incentive for this activity, it's possible research and public health uses of patient data could be curtailed.

"The central concern is that even when information qualifies as de-identified, and thus falls outside HIPAA privacy rules, it could possibly be re-identified by 'computer geeks' once it gets posted on the Internet," eCliniqua reports. Peddicord believes HHS likely will issue guidance in 2010 to encourage greater de-identification of patient information that "may render data more expensive and/or less useful," the newsletter says.

for more:
- read this eCliniqua story

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