Big Pharma Moves Will Fuel Greater PKI Adoption, Expert Says

IR last week.

“The major pharmaceutical companies — Pfizer, J&J, AstraZeneca and Merck, among others — are looking at PKI as a solution” to protecting edata, especially when it comes to electronic data capture and speeding up clinical trials, he said.

Cybertrust, a provider of information security products and services based in Herndon, Va., will develop and implement the technology platform required for interoperability among PKI encryption systems in the SAFE network.

PKI advocates say it provides organizations with the ability to digitally sign and encrypt critical data, allowing it to be deciphered or viewed only by those individuals holding a digital certificate or legitimate credentials. “PKI is perhaps one of the most valuable identity and access management solutions on the market today due to its ability to both digitally sign and encrypt data,” Greco wrote in a recent column for CSOonline.com.

While other common access management tools also involve user names and passwords, one-time or multi-factor authentication tokens and biometrics that include finger or iris scans, those tools aren’t as effective as PKI because they can’t encrypt data, Greco said. They also do not offer as robust an esignature capability, he added.

Forget the HypePIR last month (PIR July 19). SAFE-BioPharma Association is the nonprofit association that created and manages the SAFE digital identity and esignature standard for the pharmaceutical and healthcare industries.

Shields-Uehling offered this example: Submitting an Investigator Statement (Form 1572) signed with SAFE digital signatures can save a company $159. Individually that may not sound like a lot, but given that almost 240,000 forms are currently submitted to the agency on paper per year, the savings could add up, she noted.

What Is Driving Increased PKI Usage?

PKI usage is on the rise in the pharmaceutical industry, Greco said, in part because of SAFE’s desire to use it to shorten clinical trials. Using PKI will speed the movement of clinical trials from paper to electronic format, he said. It will also help FDA-regulated life sciences companies with far-flung operations to do a more efficient, faster job of getting online credentials into the right hands, he added.

PKI usage is also being driven by regulations, he added. Implementing a managed PKI security strategy is widely seen as a way to demonstrate compliance with Part 11, Sarbanes-Oxley, the Health Insurance Portability and Accountability Act, Gramm-Leach-Bliley and HSPD-12, the federal government’s federal employee ID program.

But activity outside the traditional regulated life sciences marketplace is perhaps fueling PKI’s growth even more, Greco noted. Many internet commerce firms are looking at expanding its usage when they sell goods online, he said.