1. HIPAA Security CMS - Office of HIPAA Standards (OHS) January 12, 2005 Dianne Faup

2. Regulation Dates • Published February 20, 2003 • Effective Date April 21, 2003 • Compliance Date: • No later than April 20, 2005 for all covered entities except small health plans • No later than April 20, 2006 for small health plans (as HIPAA requires)

3. General Requirements - 164.306(a) • Applies to Electronic Protected Health Information (PHI) • That a Covered Entity Creates, Receives, Maintains, or Transmits

4. General Requirements • Ensure • Confidentiality (only the right people see it) • Integrity (the information is what it is supposed to be – no unauthorized alteration or destruction) • Availability (the right people can see it when needed)

5. General Requirements • Protect against reasonably anticipated threats or hazards to the security or integrity of information • Protect against reasonably anticipated uses and disclosures not permitted by privacy rules • Ensure compliance by workforce

6. Regulation Themes • Scalability/Flexibility • Covered entities can take into account: • Size • Complexity • Capabilities • Technical Infrastructure • Cost of security measures • Potential security risks

7. Regulation Themes • Technologically Neutral • What needs to be done, not how • Comprehensive • Not just technical aspects, but behavioral as well

8. How Is This Accomplished • Standards Are Required but: • Implementation specifications which provide more detail can be either required or addressable.

9. Addressability • If an implementation specification is addressable, a covered entity can: • Implement, if reasonable and appropriate • Implement an equivalent measure, if reasonable and appropriate • Not implement it and document why • Decisions based on sound, documented reasoning from a risk analysis

10. Maintenance • Implemented security measures for compliance must be reviewed and modified as needed to continue reasonable and appropriate protections

11. What are the Standards? • Six main Sections: • 164.306: Security Standards: General Rules • 164.308: Administrative Safeguards • 164.310: Physical Safeguards • 164.312: Technical Safeguards • 164.314: Organizational Requirements • 164.316: Policies and Procedures and Documentation Requirements

12. Appendix A in Regulation • End of regulation, chart lists each standard, its associated implementation specifications, and if required or addressable

13. Example General Implementation Approach • Do Risk Analysis – Document • Based on Risk Analysis, determine how to implement each standard and implementation specification – Document • Develop Security Policies and Procedures – Document • Implement Policies and Procedures • Train Workforce • Periodic Evaluation

14. CMS/OHS HIPAA Resources • http://www.cms.hhs.gov/hipaa/hipaa2/ - CMS HIPAA Administrative Simplification Website for Electronic Transactions and Code Sets, Security, and Unique Identifiers • AskHIPAA • Roundtables

15. New HIPAA Security FAQs • Published 13 new HIPAA Security FAQs to the CMS HIPAA A.S. website (8/12/04) • Topics include: • PHI Coverage • Compliance and Certification • Risk Analysis, Management and System Vulnerabilities • Physical Safeguards • Encryption and other technical safeguards • NIST publications

16. Summary • Scalable, flexible, technology neutral approach • First step is risk analysis • Standards that make good business sense • Provided two year implementation