Safe-BioPharma Recommends DEA Use Existing Federal Infrastructure to Manage ePrescriptions for Controlled Substances

October 14, 2008 2:55 PM EDT

FT. LEE, N.J.--(BUSINESS WIRE)--

SAFE-BioPharma Association has advised the Drug Enforcement Agency (DEA) that use of PKI-based digital signatures is the safest, most secure and practical way to manage electronic prescriptions for controlled substances. The formal recommendation was made during the comment period on 21 CFR Parts 1300, 1304, et al., Electronic Prescriptions for Controlled Substances (Proposed Rule Docket No. DEA-218).

SAFE-BioPharma, the non-profit association that created and manages the SAFE-BioPharma(TM) digital identity and signature standard for the pharmaceutical and healthcare industries, recommended that DEA utilize the federal government's existing Federal Bridge Certification Authority (FBCA) infrastructure as the framework for DEA's rule for ePrescribing controlled substances.

"The FBCA is a widely available and supported system, and it provides a level of security, non-repudiability, interoperability and auditability required by legislation covering prescribing of controlled substances. Such a system would provide strong evidence that the original prescription was signed by a DEA-registered practitioner, that it was not altered after being signed and transmitted, and that it was not altered after received by the pharmacist," the recommendation states.

The association also recommended that each healthcare professional have a single digital identity that can be used in ePrescribing, authentication to healthcare networks, access to health records, ordering diagnostic tests, and myriad other electronic functions in many different settings. Through the FBCA, these digital identities will interoperate with applications across government agencies including the Department of Health and Human Services, Centers for Medicare and Medicaid Services, FDA, NIH, VA, Department of Defense, Homeland Security, and within the private sector.

The FBCA framework meets the requirements for privacy, security and confidentiality required by the healthcare sector for the exchange of sensitive healthcare information. It also meets DEA requirements for identity trust assurance, non-repudiable digital signature, date and date stamping, record integrity and auditability in ePrescribing controlled substances.

    The complete recommendation can be found at
http://www.safe-biopharma.org/infocenter/

    SAFE-BioPharma_Recommendations_to_Drug_Enforcement_Agency.pdf.

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About SAFE-BioPharma Association

SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma(TM) digital identity and signature standard for the pharmaceutical and healthcare industries. The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. It facilitates interoperability by providing a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in electronic transactions. SAFE-BioPharma's vision is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012. The Association's members include Amgen (NASDAQ: AMGN), AstraZeneca (NYSE: AZN), Bristol-Myers Squibb (NYSE: BMY), Genzyme (NASDAQ: GENZ), GlaxoSmithKline (NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), Pfizer (NYSE: PFE), Procter & Gamble (NYSE: PG), Roche and Sanofi-Aventis (NYSE: SNY). For more information, visit www.safe-biopharma.org.

SAFE-BioPharma(TM) is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

Source: SAFE-BioPharma Association

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