By Lisa Seachrist

Washington Editor

WASHINGTON - Sen. Jim Jeffords' (R-Vt.) effort to create a bipartisan bill to protect the confidentiality of medical records hit a snag this week just as it was about to be endorsed by the Health, Education, Labor and Pensions Committee, which Jeffords chairs.

A provision that would permit patients to sue anyone who intentionally violates the rights and protections established in the Health Information Confidentiality Act by misusing the information has run up against Republican opposition.

"It became clear that there was going to be a Republican move to strike the private right of action clause and that the amendment was going to pass," a committee spokesman told BioWorld Today. "That in turn could make some Democrats vote against the bill. The chairman decided to see if we can't resolve this issue before it comes before the committee."

Jeffords has rescheduled consideration of the bill until June 9 to see if a compromise can be reached. A Jeffords spokesman noted that this was the only issue with the potential to break bipartisan support of the bill, and the environment within the committee appeared to favor working the issue out.

While the right to sue for misuse of information hangs in the balance, the issues that could stymie biomedical research appear to be finding resolution. Michael Werner, bioethics counsel for the Biotechnology Industry Organization (BIO), evaluated the May 21 version of the bill and authored a letter to Sens. Bill Frist (R-Tenn.) and Edward Kennedy (D-Mass.), who are heading the efforts to craft legislation that doesn't inhibit research.

"We are pretty comfortable with the bill as it is written," Werner said. "BIO has always supported a statute to protect patient information along with the real need to encourage biomedical research."

Werner praised the effort that removed a provision for external review boards for research not subject to the common rule. Those review boards would create an unnecessary layer of bureaucracy that would hamper research, he noted.

In addition, BIO supported the bill's definition of "nonidentifiable information" as including information that is coded, encrypted or otherwise made anonymous.

However, Werner told the senators that the "preemption language in the bill works at cross-purposes to these provisions and will hurt research." Because most clinical trials are multi-center, multi-state endeavors, testing new therapies requires sponsors to comply with the laws of every state where the drug is being tested.

"We were hoping for a federal ceiling for privacy protections," Werner said. "It just makes sense. Clinical trials are national studies - privacy protections should be national as well."

For example, a confidentiality statute in Minnesota that makes obtaining consent difficult and requires researchers to obtain informed consent for all uses of medical information has created an atmosphere that impairs research efforts, Werner noted. If other states adopt that standard and a patchwork quilt of protections develops, researchers could find it increasingly difficult to conduct clinical studies.

Werner suggested that if the committee couldn't agree to federal preemption of the state laws for all of the provisions in the bill that, perhaps, they could agree to provide a federal preemption for research uses of information.

"We are hoping for a federal preemption for research," Werner said. "At the very least, there should be a consensus privacy standard for national research studies."

The bill remains a work in progress. On Friday evening, it had a provision that would make it difficult for FDA to carry out its post-market surveillance activities. However, the staff had altered the language by Monday to eliminate this problem as well as provide patients with protections from drug companies using the surveillance information for marketing.

"My sense is that the committee, in a bipartisan way, figured this out and fixed it," Werner said. "We remain hopeful that we will get preemption. We are also confident that the research provisions are no longer a subject of controversy." n