Digital signature meets crypto time-stamp

The SAFE-BioPharma Association's digital signature standard is now linked with a cryptographic time-stamp service. Authenticity-specialist Surety is offering an enhanced version of its AbsoluteProof date and timestamp seal augmented with the identity-management standard.

Beyond its use for discovery IP protection, the document authenticity one-two punch has use in regulatory filings: Guidance from both the FDA and the European Medicines Agency supports the use of SAFE-BioPharma digital signatures on submissions. Since 2006, SAFE-BioPharma members have submitted "tens of thousands of digitally signed documents to the FDA," says SAFE-BioPharma spokesman Jon Weisberg in an email. In Japan, efforts are underway to have regulators accept the digital signature standard.

Through the augmented AbsoluteProof service, researchers can digitally sign their work and virtually seal it, locking down the time of creation in a legally defensible manner, according to Surety. And VP Bob Flinton says in an email that computer evidence processed with AbsoluteProof technology has been admitted in civil and criminal cases. He's unaware of any challenges to the virtual seal on authentication grounds.

Surety guarantees defensibility against "the most rigorous legal challenges to the content's authenticity," according to an announcement.

- see the Surety announcement

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.