Industry Interview: Adapting Digital Signatures into your Organisation

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Mollie Shields-Uehling

The world is becoming an electronic landscape and businesses are no longer paper-based. The digital signature is replacing the wet signature in all organisations, reducing time and costs and can be used globally. Mollie Shields-Uehling, President & CEO, Safe Bio-Pharma Association explains.

SmartLab Exchange: Digital versus electronic signatures at SAFE Bio-Pharma, are transitioning the bio-pharmaceutical and healthcare community to fully electronic communities, what are the benefits of digital signatures?

M Shields-Uehling: Using digital signatures is transformative. Businesses become fully electronic and, consequently, more efficient and more productive. This transformation is made possible because digital signatures, unlike common “electronic signatures,” are uniquely linked algorithmically to the individual’s proven identity. This assures that the identity of the person behind the signature can be trusted. The signature is legally enforceable in the world’s major jurisdictions, and the signature meets regulatory requirements in all leading regulatory jurisdictions.

Business processes are struggling to keep up with electronic communications. Paper-related processes like scanning, faxing, email attachments, and courier use no longer cut it. We need to focus on full electronic immersion -- creating the document electronically, modifying it electronically, signing it electronically, and exchanging it electronically.

SmartLab Exchange: So what is the difference between an electronic signature and a digital signature?

M Shields-Uehling: Common electronic signatures are vulnerable because there is no identity linkage. The laboratory, regulatory body or court of law doesn’t know whether or not the signatory actually applied the signature. It might be as simple as a faxed version of a wet signature.

Digital signatures remove the vulnerability by linking the signer’s proven identity to the signature.

There are additional advantages to digital signatures. If a digitally signed document is changed, the viewer knows it immediately because the signature is invalidated. You may never know that an electronically signed document had been changed. Digital signatures are also persistent; they can be validated at any time now or in the future. This is extremely important in protecting intellectual property. Common electronic signatures simply don’t provide sustainable levels of protection.

SmartLab Exchange: The development of secure digital signatures obviously has been critical to the adoption of informatics systems. Could you give us some clear reasons as to why this is?

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M Shields Uehling: Identity trust is the fundamental issue in electronic systems -- the assurance that you can trust the identities of those accessing your sensitive information. Unfortunately, business is applying industrial era policies to the information age. Most organizations require a separate identity for anyone entering their enterprise. Instead, we should strive for universal identities that are interoperable with multiple information systems.

The SAFE-BioPharma digital identity standard supports – a single, universal, portable identity and digital signature that can be used with all partners across multiple systems. Users need only one digital identity to deal with multiple sponsors, multiple regulatory agencies and to conduct all of their work in the cloud.

SmartLab Exchange: Can these signatories be used or adapted to other industries?

M Shields Uehling: Digital signatures are about productivity improvement and cycle time reduction. They are being utilized in multiple industries and by the US federal government. Among others, they’re used in financial services, telecommunications, aerospace and defence, and atomic energy. There are initiatives to make all of these identities interoperable – meaning broader bilateral trust of digital identities between multiple enterprises. This exists between SAFE-BioPharma and US Government agencies. And there are similar efforts underway that will result in being able to trust different digital identities across Europe.

SmartLab Exchange: Have you any case studies that you could share with us of an organisation that has adopted digital signatures and perhaps discuss the challenges they overcame?

M Shields Uehling: Digital signatures are used extensively to sign electronic lab notebooks, chemical lab notebooks, and bio books. Scientists no longer have to hold signing parties, they can sign anywhere in the world if they have internet access. It makes the process fully electronic and provides much more rigour in terms of defending patents and other challenges. There have been hundreds of thousands, if not millions of regulatory submissions to the FDA using digital signatures.

The European Medicines Agency and the FDA have publicly stated that they’re on path to fully electronic receipt, review and respond systems. In the future, we'll see all clinical data signed and submitted electronically. We're seeing the initial cases of that today. Regulatory document management systems have adapted to support the SAFE-BioPharma standard.

The greatest growth of SAFE-BioPharma digital identities and signatures is in the area of collaboration. External partners, particularly clinical investigators authenticate into websites to gain access to clinical trial documents, sign their contracts, and submit their background information.

In the United States we see huge use of SAFE-BioPharma digital signatures associated with electronic prescribing of controlled substances. The Drug Enforcement Administration requires a strong level of trust in a digital signature related to electronic prescribing of controlled substances. Some 400,000 prescribers now in the process of receiving digital identity credentials that are compliant with the SAFE-BioPharma standard.

SmartLab Exchange: I understand that you will be speaking about the National Cancer Institute and research partners at the SmartLab Exchange and their use of identities, signatures and, indeed, cloud computing to accelerate their drug development. Can you elaborate a little bit more on the work that they're doing?

M Shields Uehling: The National Cancer Institute is the largest conductor of clinical trials in the world. At any given time they have 800 to 900 trials underway. They have some 33,000 patients enrolled and they have multiple, multiple partners, sponsors, major pharmaceutical companies and small companies as well as many clinical researchers, both in academia and in private practice.

NCI has an elaborate study initiation process whereby many documents have to be signed, submitted and exchanged before a study starts. SAFE-BioPharma and the National Cancer Institute have been using a signing application that allows NCI researchers and their private sector counterparts (in this case from Sanofi and Bristol-Myers Squibb) to put trial start-up documents, in the cloud where, using the signing application, they’re signed. Once signed, the signing app notifies the originator and the document is taken off the signing app and executed. This process is possible because the SAFE-BioPharma digital identity credentials used by the company researchers are interoperable with the government identity credentials used by the NCI researchers. There is bilateral identity trust.

The process allows the National Cancer Institute to reduce the amount of time and cost to start a study. Among the hard costs NCI eliminated are couriers, scanning, photocopying, etc. Although they have not yet calculated personnel costs for those and other functions, NCI saved 2.2 hours for every transaction and for every wet signature that was replaced by digital signature. NCI is now moving into production with this application and will expand it to a variety of business processes.

SmartLab Exchange: What are you looking forward to most at this year's SmartLab Exchange event?

M Shields Uehling: I’m looking forward to discussing the success of SAFE-BioPharma member companies using interoperable digital identities to move business and research collaboration to the cloud.