SAFE-BioPharma, and what feels safe

By Ellen Messmer, NetworkWorld.com, 06/02/06

George Rathbun, director of IT architecture at Pfizer, recently shared his thoughts about the security measures crafted for information sharing in the biomedical industry under the collaborative effort known as "SAFE-BioPharma." Some of the ideas the biomedical companies are coming up with may have relevance for other industries, too.

SAFE-BioPharma has several companies, including Johnson & Johnson, Merck and GlaxoSmithKline, collaborating on a digital certificate cross-certification.

The purpose is to have physicans and others in the medical field use digital certificates to sign and encrypt electronic documents, especially those related to research. Today, research documents are more commonly paper based and have to be signed by hand.

One comment that Rathbun made in the interview with Network World concerned the relative importance of using hardware-based certificates rather than the software-based type.

In the case of SAFE-BioPharma, the lawyers scrutinizing the difference on behalf of the organization's membership have taken the position that electronic documents signed using hardware-based tokens would probably hold up under scrunity in court better than PC-based certificates.

This hasn't been challenged in any legal setting to date, but lawyers tend to think defensively. However, Rathbun noted the issue is an open one, with the Food & Drug Administration saying they would consider software certicates for submissions of digitally signed documents.

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