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Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution

Mollie Shields-Uehling
Posted: 10/04/2011

Some people say that the answer to life is in the nature of the questions we ask. I believe the same is true when it comes to making good business decisions.

In a world that is going digital faster than it knows how to control the technology and its endless uses, asking the right questions can help avoid the kinds of decisions that deliver less than optimal results.

This is especially true when selecting digital identity and signature solutions.

We need to inquire about regulatory acceptance and the ability for a digital identity to be used in the world at large – not merely within the confined space of an individual company or the closed world of a slightly larger community.

The reality is that each of us and our respective employers exists in an ever-expanding cyber-community of other companies, government agencies, academia, CROs, etc. We need to be able to exchange and sign electronic information securely, seamlessly, and with full knowledge that the identity on the other end of the screen is truly who he or she asserts to be.

Digital identities and digital signing solutions that are compliant with the SAFE-BioPharma digital identity and digital signature standard provide distinct advantages over other commercially available digital signature solutions.

When evaluating any digital identity or digital signature solution, ask these questions. The answers will help determine if you’re about to get full value for this important decision

 1.   Does it allow a single identity credential to replace multiple credentials (and user names and passwords)?

Many solutions will add yet another user name and password to the multitude of user name and password combinations that executives, clinicians and others are burdened with across the globe. The option is a universal credential that can be used in any context. Think of it as the universal remote control that replaces the ones for the TV, the DVD, radio, etc., etc. Credentials compliant with the SAFE-BioPharma standard are becoming universal. One highly secure and totally versatile SAFE-BioPharma credential allows every user to clean out his or her cluttered credential closet.

2. Is it interoperable with digital identity credentials used by other organizations, including FDA, NIH, EMA, etc?

Identity credentials based on the SAFE-BioPharma standard are interoperable with US government regulatory and other agencies and with other organizations across the life sciences and other industries. That means that the credentials are trusted by an ever-expanding global trust community incorporating both public and private sectors.

If the credential is not interoperable, a) its use will be limited in its ability to authenticate the identities of external collaborators, such as clinicians accessing clinical portals, and b)it also will be limited in its ability to apply legally binding signatures.

3. Is it linked to an actual, vetted individual identity?

Many identity credentials are issued in a manner that does not tie the user’s identity to the credential. Among the disadvantages is that you don’t really know if the identity is valid – a problem when dealing with legal and regulatory compliance. A digital identity based on the SAFE-BioPharma standard is tightly bound to the closely examined identity of the individual to whom the digital credential is assigned.  This procedure and the legal agreements the individual signs provide the ability to manage who can have access to what.

If the credential is not tightly bound to the user’s identity it cannot be used to manage access to portals, health and other confidential records, physical facilities, etc.

4. Is it legally-binding and non-repudiable?

Identity credentials based on the SAFE-BioPharma standard allow the user to apply legally binding digital signatures to a wide variety of electronic documents including laboratory notebooks, submissions, contracts, forms, etc.

Signature solutions not based on the SAFE-BioPharma standard may allow electronic signatures to be applied by someone other than its authorized user. The signature will not be non-repudiable (a unique consideration that prevents a signatory from denying a signature was applied).

5. Does it have widespread regulatory compliance?

Many digital identity and digital signature solutions are not. The SAFE-BioPharma standard is 21 CFR Part 11 compliant. It was developed with participation from the US Food and Drug Administration and the European Medicines Agency. The SAFE-BioPharma privacy policy is compliant with the US Department of Commerce and EU Safe Harbor requirements for protection of personal data.

6. Is it DEA compliant?

Digital signatures based on the SAFE-BioPharma standard have been cited by the US Drug Enforcement Agency as acceptable for applying electronic signatures to ePrescriptions for controlled substances. This capability is critically important for the rapidly changing world of ePrescribing.

Most of the world’s most successful biopharmaceutical companies have asked the right questions about their choice of digital identity and digital signature solutions. They have concluded that compliancy with the SAFE-BioPharma standard is the most important answer. 

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Mollie Shields-Uehling
Posted: 10/04/2011