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HIPAA Security Final Rule Overview for HIPAA Summit West June 5, 2003Karen Trudel
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Publication Information Printed in Federal Register 2/20/03 Compliance Date 4/21/05 (4/21/06 for Small Health Plans) Document can be located at www.cms.hhs.gov/hipaa/hipaa2
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Purpose Ensure integrity, confidentiality and availability of electronic protected health information Protect against reasonably anticipated threats or hazards, and improper use or disclosure
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Scope All electronic protected health information (EPHI) –NOT oral and paper PHI In motion AND at rest All covered entities
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Security Standards General Concepts Flexible, Scalable –Permits standards to be interpreted and implemented appropriately from the smallest provider to the largest plan Comprehensive –Cover all aspects of security – behavioral as well as technical Technology Neutral –Can utilize future technology advances in this fast- changing field
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Recent WEDI Policy Advisory Group Assessed need to request changes/guidance Result: a few clarifications needed; outreach needed Clarifications: –Relief from burdensome security incident reporting requirement –Clarify status of NIST Guidance documents Consensus was to preserve flexibility by not requesting official guidance
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Implementation Process Reminiscent of Y2K Phases: –Education –Assessment –Remediation –Testing/Validation
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Assessment Phase Critical Standard: Security Management Process –Risk Analysis – What are the various risks? How severe? How likely? –Risk Management – What solutions best reduce risk to an acceptable level Remember: No such thing as absolute security
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Where to Start? Leverage progress made in privacy implementation –Identified PHI –Identified business associates Build on “mini-security rule” in privacy
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What Next? Add on issues related to integrity and availability Brings into play requirements like disaster recovery
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Filling the Gaps Look at entire range of options Assess –Relative risk –How well various options mitigate the risk –Cost High tech high cost options aren’t necessarily safer
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Example: Security Awareness Training Could be done by various means: –Develop curriculum and send staff to formal classes –Develop web-based training –Take advantage of “teachable moments” New staff orientation Regular department meetings Emailed reminders Articles in company newsletter
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Remember Technology is not always the answer…many of the standards are administrative Important to: –Make supportable decisions –Document those decisions –Revisit decisions periodically to assure they are still valid
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Enforcement - General Complaint driven Penalties –$100 for each violation –Maximum of $25,000 per year for all violations of an identical requirement
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Enforcement – Issues Still studying – will be defined in Substantive Rule NPRM scheduled for publication this winter Issues include: –What is a “violation” and how are they counted –Are all standards weighed the same?
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Conclusion Concentrate on the assessment phase Consider staging remediation –“low hanging fruit” –Areas of significant risk
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