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PKI, Security, and Health Care. Rich Guida Director, Information Security. What is the Health Care “Space?”. Point-of-care providers (doctors, clinics, hospitals) Consumers (who receive the care) Insurers Product companies Research institutions Governments. Another way to parse the space.

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PKI, Security, and Health Care

Rich GuidaDirector, Information Security


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What is the Health Care “Space?”

  • Point-of-care providers (doctors, clinics, hospitals)

  • Consumers (who receive the care)

  • Insurers

  • Product companies

  • Research institutions

  • Governments


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Another way to parse the space

  • Those who typically process patient data (as Personal Health Information – PHI)

    • Point-of-care facilities

    • Insurers

    • Some research institutions

  • Those who typically do not process patient data (as PHI – instead, anonymized)

    • Most product companies and governments (other than for their own employees)


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Applicable Federal Laws/Regulations

  • Health Insurance Portability and Accountability Act (HIPAA)

    • Confidentiality and integrity of patient data (including PHI)

  • FDA 21 CFR Part 11

    • E-records and e-signatures

  • FDA “Computer Systems Validation” guidance

  • Government Paperwork Elimination Act (GPEA)

  • Electronic Signatures in Global and National Commerce Act (E-SIGN)


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Examples of Important Processes

  • Clinical trials of new drugs/devices

    • Data integrity/authenticity, and where PHI is involved, confidentiality

  • Maintaining quality assurance records on manufacturing and management

    • Data integrity/authenticity

  • Product distribution

    • Data integrity/authenticity – to guard against counterfeits

  • Billing (insurers/point-of-care providers)

    • All of the above


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Healthcare Security Today

  • Mostly userID/password-based for authentication and e-signatures

    • But strong movement towards certificate-based in many areas

  • Diverse environments mean diverse operating systems and practices

  • Health care as a whole is still evolving towards “strong computer security” principles


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Goals in Using Certificates

  • Single, unified identity for healthcare providers, globally recognized

    • Note: NOT patients!

  • Stronger e-signatures, authentication, encryption

  • Accelerate processes of getting drugs/devices through clinical trials – by reducing paperwork


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Today’s Panel

  • Terry Zagar from SAFE

    • To discuss the industry-wide initiative focusing on unified credentials based on PKI

    • Includes discussion of SAFE Bridge CA effort

  • John Landwehr from Adobe

    • To discuss how Adobe 6.0 and 7.0 fit in to SAFE’s activities with native PKI functionality


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