The biopharmaceutical industry is constantly finding new ways to work across geographical and enterprise boundaries. Companies co-develop products, cross-company coalitions are formed to improve R&D, and clinical trials are coordinated by participants across the planet.
Cloud computing makes all this possible; it reduces operational costs, frees IT personnel to focus on things other than hardware and software, stores applications centrally and provides effortless updates. Use of drivers and other hassle-prone and labour-intensive processes are eliminated.
Trust thy cyber neighbour
But there are risks that come with these rewards. Cyber-collaboration can open access to information assets including valuable intellectual property. Strong and scalable safeguards are needed to assure that only those with authorised access get through. In other words, cyber-collaboration forces us to take a hard look at the issues of who to trust and how to let them see data.
Cyber-collaboration, especially in this highly regulated industry, also requires the ability to apply legally binding and regulatory compliant cyber signatures to a broad range of cloud-stored and other electronic documents.
A growing community of life science companies is tackling these issues by provisioning executives, clinicians and others with digital identities based on standards of trust.
SAFE-BioPharma standard
The SAFE-BioPharma standard, created by the industry for the industry, is dedicated to providing standardised identity trust in cyber transactions within the biopharmaceutical and healthcare sectors. It is managed by the non-profit SAFE-BioPharma Association, which was formed and is supported by a group of biopharmaceutical companies that recognise the need for a standardised approach to trusting cyber-identities and to signing electronic documents in a way that satisfies the unique needs of our industry.
The SAFE-BioPharma standard requires that an individual’s digital identity be based on a process establishing a close bond between cyber-identity and actual identity. Once that process is completed, the identity resides in a computer or on a token, or, increasingly, in a highly secure hardware module in the cloud. Regardless of the form in which it is stored, the identity is universal and can be used for authorised access to information stored behind company gateways, portals and firewalls.
An individual with a SAFE-BioPharma identity may use it as a single internet identity with all partners. The standard also requires compliance with certain rules and regulations and the understanding that disagreements between participating parties will be resolved through the London Court of International Arbitration, rather than be disputed in a court of law.
Because each SAFE-BioPharma digital identity credential is closely bound to the individual using it, it also can be used to apply legally binding digital signatures to electronic documents. These signatures are different from other forms of electronic signature. Once applied, the signature protects the document by graphically indicating if the document has been changed after signing. Documents bearing SAFE-BioPharma signatures also are easily audited, saving individuals and organisations time and resource.
The recently introduced cloud-stored mobile identity credential can be accessed and used at any time and any place there’s internet access. This capability accelerates processes by eliminating the time lost waiting for traditional wet signatures and other unproductive, paper-related activities. It can be used with multiple devices including smartphones, tablets, one-time password tokens, or voice calls to home and/or office lines.
Participation in the SAFE-BioPharma standard also assures that a SAFE-BioPharma digital identity will be trusted by a wide range of regulatory bodies and governmental entities, as well as other organisations within life sciences and even organisations in other industries. The mechanics allowing for this trust are complicated and conducted behind the scenes through the ongoing efforts of negotiating agreements and checking that what SAFE-BioPharma has certified as a community of trust will be accepted by other established and developing communities of trust. Importantly, one of these communities is the US Federal Government, including agencies such as the US Food and Drug Administration and the National Institutes of Health.
Signing ePrescriptions for controlled substances
In the US, where prescribing controlled substances requires filing multiple forms, digital signatures complying with the SAFE-BioPharma standard have been identified by the US Drug Enforcement Agency as appropriate for signing electronic prescriptions for these medicines.
Consequently, one of the world’s largest telecommunications companies has built a portion of its biopharmaceutical and healthcare enterprise on digital identities that are based on the SAFE-BioPharma standard and is in the process of issuing hundreds of thousands of compliant digital identity credentials to physicians throughout the US.
New applications compliant with the standard
The developers of software applications used throughout the industry are taking steps to certify their applications are compatible with the SAFE-BioPharma standard. Most recently, DocuSign, which leads in the eSignature transaction management space, has partnered with SAFE-BioPharma to deliver its services to companies and individuals using digital credentials compliant with the SAFE-BioPharma standard.
DocuSign is using the partnership to increase its presence in biopharmaceutical and healthcare entities. The company has more than 27 million users in 188 countries and is adding more than 50,000 new users every day.
This new capability is expected to accelerate the use of the standard to apply digital signatures to a host of new applications currently being explored by companies in the US, Europe, and Japan, further enhancing its use in cyber-collaboration.
Demonstrating effective cyber-collaboration at NCI
Perhaps nothing demonstrates the collaboration-enhancing ability of trusted cyber-identity credentials more effectively than the ongoing study between a group of company cancer researchers and their counterparts at the National Cancer Institute. The project has demonstrated significant cost and time savings by accessing and signing cloud-based clinical trial documents.
All participants use interoperable digital identity credentials. The company scientists have SAFE-BioPharma digital identity credentials. The government scientists have US Government-issued digital identity credentials. Some years ago, SAFE-BioPharma went through a rigorous process to demonstrate to the US Government that its digital identity credentials met the criteria that would allow them to be trusted by government agencies.
Indeed, SAFE-BioPharma is the only standard representing the life sciences that has this standing. Because of this interoperability, SAFE-BioPharma identities are trusted by the government and government identities are trusted within the SAFE-BioPharma context.
In the NCI study, the process of obtaining forms, letters and other documents involved in the trial start-up process has become entirely paperless. No paper means no shipping costs or delays. It means being able to sign documents from any place, a distinct advantage over waiting to sign until you’re back in the office. The paper-based roadblocks that had resulted in weeks or months of delay in getting a trial up and running are being eliminated.
When this simple-to-implement and elegant solution is extended to other clinical trials and related processes, medicines will go to market more quickly, helping the patients who need them and helping the companies that make them recoup their investments more quickly.
Take that concept of cyber-collaboration and apply it to any other scenario and the outcomes will be equally encouraging. Trusted and interoperable digital-identity credentials that are used to authenticate into portals and systems and to apply legally binding digital signatures are the key to effective cyber-collaboration in healthcare and the life sciences.
