Nobody Knows You’re a Dog

A few years ago, The New Yorker magazine published a cartoon of two dogs sitting in front of a computer monitor. One was explaining to the other: “On the Internet, nobody knows you’re a dog.”

Given the regulated nature of the global biopharmaceutical industry, the explosion in global collaboration, and our reliance on the Internet, it is absolutely essential that we know and trust the identity of people on the other side of the screen.

Basically, faith in electronic processes is a function of trusting identities of people we don’t know – a serious complication in the regulated, highly collaborative, global biopharmaceutical industry. 

Additionally,  to make our dealings truly electronic – and to eliminate the excessive cost and time associated with handling, shipping, storing and accessing paper documents –  the people who possess those identities need a way to sign electronic documents in a manner that can be trusted and that will stand up to legal review.

Several years ago, a group of IT visionaries from the world’s largest biopharmaceutical companies foresaw these needs.  They reasoned that a standardized way to establish digital identities and to apply digital signatures to electronic documents would discourage development of a patchwork of costly systems unable to communicate with each other. They also reasoned that if the standard were interoperable with similar systems used by government agencies and in other industries, it would facilitate collaboration and ease communications with global regulatory agencies.

The result of this pan-industry effort – including cooperation from the US Food and Drug Administration and the European Medicines Agency.-- is the SAFE-BioPharma digital standard, designed specifically for the life sciences to mitigate the risks inherent in electronic transactions.

The group also created a non-profit organization – SAFE-BioPharma Association -- to manage the standard’s development. The association’s vision is to help catalyze the transformation of the biopharmaceutical and healthcare communities to a fully electronic business environment by 2015, and in the six years it has been functioning, it has progressed steadily toward that goal.

While the technology behind the standard is complex, the way it is used is quite simple – increasingly in the form of a password in some combination with software in the cloud and an existing device such as a cellphone.

Part of the standard’s unique characteristic is that it provides each user with a digital identity that is closely linked to that user’s carefully vetted, actual identity. This allows the individual to be identified every time a signature is applied to an electronic document. The result, unlike common electronic signatures, is a signed document that is legally-binding and non-repudiable.

No canines pretending to be something they aren’t.

Among numerous other unique aspects of the standard is that it meets the EU Advanced Electronic Signature Directive. Documents and transactions shared with external parties in Europe or within the US federal government need the strength of a digital signature that is tightly bound to the identity of the signer. Because of this requirement, SAFE-BioPharma digital signatures are the only solution for European submissions.

Separately, but of equal importance, SAFE-BioPharma is the only solution cited by the US DEA as suitable for electronically signing prescriptions for controlled substances. The signatures also are compliant with (US) HIPAA regulations

The standard is used for a broad range of applications by large and small biopharmaceutical companies. Among the most common are signing electronic laboratory notebooks, contracts, and a spectrum of regulatory submissions.

But the application that currently is attracting the greatest interest is clinical trial management. It makes a lot of sense, given the global expansion of clinical development, the need to track many participants in many sites, and use of the Web as an alternative to relying on hard copies and moving them around using FedEx, DHL and fax.

This relevance is being demonstrated in an ongoing pilot program involving scientists in the National Cancer Institute (the world’s largest sponsor of cancer treatment clinical trials) and scientists in Bristol-Myers Squibb and sanofi-aventis.

The numerous documents associated with the start up process have been placed in the cloud where the scientists are able to access, amend and sign them using their interoperable digital identities. The industry scientists use SAFE-BioPharma digital identities, and the NCI scientists use their U.S. government-issued digital identities.

Because the two types of digital identities are interoperable (an identity asserted by SAFE-BioPharma will be trusted by US federal agencies, among other inter-connected cyber communities), the scientists have been able to greatly reduce the time and costs associated with starting a clinical trial.

Many who have reviewed the pilot feel it is an important milestone in the use of secure cloud computing to streamline the future of the clinical trial process. They see how interoperable digital identities allow sponsors and CROs  to transition safely and easily to fully electronic processes in efficient and cost-effective on-line collaborations with vendors, suppliers and regulatory agencies.

SAFE-BioPharma is a standard with widespread buy-in. Many biopharma lawyers, researchers, and managers rely on it. Many are in the process of learning about the benefits. In the United States digital identity credentials compliant with the SAFE-BioPharma standard soon will be in use by hundreds of thousands of clinical investigators and other practicing physicians.

The minds that created SAFE-BioPharma developed a digital identity and digital signature standard that would improve operations wherever it was put to work. That has been demonstrated repeatedly.

Even those two dogs in front of the computer screen would consider the SAFE-BioPharma standard to be best of class.

In future columns, I’ll explain new ways the biopharmaceutical industry is using the SAFE-BioPharma standard to improve efficiencies and reduce costs.

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