Information Security and Privacy: HIPAA’s Potential Impact

1. Information Security and Privacy: HIPAA’s Potential Impact Gordon J. Apple Attorney at Law, Law Office of Gordon J. Apple, St. Paul, MN Lee Olson Information Security Officer, Mayo Foundation, Rochester, MN

2. Program Objectives • Overview of data security/privacy issues • Review of HIPAA security standards • Review of HIPAA privacy standards • Facing HIPAA challenges

3. Existing Data Protection Requirements • State law • Federal law • JCAHO • Conditions of Participation • Professional codes

4. New HIPAA Requirements • Standards for electronic transactions and code sets • National standard health care provider identifier • National standard employer identifier • Security and electronic signature standards

5. New HIPAA Requirements cont’d • Standards for privacy of individually identifiable health information • National standard for health claims attachment • National standard identifiers for health plans

6. I. Overview of Data Security and Privacy Issues

7. Privacy • “The right to privacy is an integral part of our humanity; one has a public persona, exposed and active, and a private persona, guarded and preserved. The heart of our liberty is choosing which parts of our lives shall become public and which parts we shall hold close.” • Minnesota Supreme Court 582 N.W.2d 231, 1998

8. The Power of Anecdotes

9. Data Mining • Develop clinical pathways to improve patient care • Develop drug formularies • Develop marketing opportunities?

10. CVS Case • Pharmacy records • Alleged misuse • PR firestorm • Class action litigation

11. “It is only slightly facetious to say that digital information lasts forever - or five years, whichever comes first.” Jeff Rothenberg Scientific American, Jan. 1995

12. Geek Speak • Firewall • Hacker • Bandwidth • Router • Port • Probes • TTP

13. Geek Speak II • CA • PKI • PKE • PKE • LAN • ISP

14. Wetware

15. II. General Review of HIPAA Security Standards

16. Security • “The purpose of security is to protect both the system and the information it contains from unauthorized access from without and misuse from within.” • Three aspects to consider • confidentiality • integrity • availability

17. Security Standards: Applicability Applies to any health plan, provider or clearinghouse that electronically maintains or transmits any individually identifiable health information, internally or externally

18. Security is risk management

19. Risk Management Process • Quantify assets, risks and threats • a mix of the objective and subjective • need not be complicated • Determine cost-effective security controls • protect what’s worth protecting & don’t worry about the rest • The government is big on this • mainly because the government is big • approach statistical mean

20. Risks • Passive, always in the background • fires, floods, power outages, equipment failure • predictable on a large scale & statistical in nature

21. Threats • Active, evolving, never static • Goal: defeat security • people oriented • hackers, viruses, insiders, disgruntled persons • must be actively managed by security professionals

22. 1. Administrative Procedures • Guard data confidentiality, integrity and availability • Policies and procedures • written • communicated • enforced

23. Administrative Requirements Certification Chain of trust partner agreements Organizational policies, practices and procedures Access controls Internal audit Personnel security Configuration management Incident response Termination procedures Training

24. 2. Physical Safeguards • Appointment of security czar • Physical access control • Workstation usage • Media & output controls • Locks, keys, tokens… • Termination procedures • Backup

25. 3. Technical Security Services • System Level Features • System access • user identification and authentication • Entity authentication • Data authentication • Authorization control • discretionary access to data • least privilege principle • Audit controls

26. 4. Technical Security Mechanisms • Communications & network controls • firewall management • access controls • alarms • audit trail • encryption • event reporting • integrity controls

27. 5. Electronic Signature • Must implement three characteristic features: • message integrity • non-repudiation • user authentication • Digital signature provides these

29. Getting Started:Gathering Current State Information • Translate requirements • 38 pages of single-spaced legalese-- don’t try this at home • HIPAA EarlyViewTM tool • developed by NC Information & Communication Alliance • cost effective, uncomplicated, user friendly license • saves lots of work • generates reports useful for gap analysis • http://www.nchica.org/activities/EarlyView/More_info.htm

30. Organizational Assessment • Conduct survey in bite-sized chunks • Different systems & applications have different security attributes • Clinical systems • Clinical operations support • Finance & electronic commerce • Laboratory services • Business & HR systems, etc.

31. Logistical Considerations • Consider geography, complexities & capabilities • Who will collect & analyze the data? • Information Security Officer’s role • Stewards & Administrators’ roles

32. Pitfalls to Avoid • Overanalyzing the requirements & process • Leads to corporate constipation • Academics need to put on their operational hats • Garbage in, garbage out • Must understand the goal & process • Effective communication & buy-in essential • Don’t sweat the details…. for now • Use a top down approach, not Band Aids

33. Develop Implementation Plan • Strategy must address both administrative & technical levels • coordinate with e-commerce • awareness & education • initiate process changes • modify systems & applications • replace systems & applications • Final rule may necessitate minor course changes

34. Sources Minnesota Health Data Institute http://zen.mhdi.org/ North Carolina Healthcare Information and Communication Alliance http://www.nchica.org/ Massachussetts Health Data Consortium http://www.mahealthdata.org Workgroup for Electronic Data Interchange http://www.wedi.org HIPAAlert news briefs published by Phoenix Health Systems, Inc. http://hipaalert.com

35. III. General review of HIPAA Privacy Standards

36. Covered Entities • Health plans • Health care providers who transmit PHI in electronic form in connection with standard transactions • Health care clearinghouses • Short list indirectly expanded through business partner requirements

37. HIPAA Data • Heath information • Individually identifiable health information • Protected health information (PHI)

38. Protected Health Information • Individually Identifiable Health Information that is or has been electronically transmitted or electronically maintained by a covered entity and includes such information in any other form (printout of electronic data) 45 CFR 164.504

39. Uses and Disclosures of Protected Health Information • To carry out treatment, payment or health care operations • With patient consent • No consent, but for public health, health oversight, judicial/administrative proceedings, coroners/MEs, law enforcement, …. 45 CFR 164.510

40. Uses and Disclosures Requiring Patient Consent • Requests by patient • Request by CEs re: marketing, fundraising, employers for employment determinations, non-health related divisions of the CE… 45 CFR 164.508

41. Fair Information Practices • Series of individual rights • General rule on disclosure • “Minimum necessary”

42. Minimum Necessary • To meet the purpose of the use or disclosure • To limit access only to those people who need access to the information to accomplish the use or disclosure.

43. Notice of Information Practices • An individual has a right to adequate notice of the policies and procedures of a covered entity that is a health plan or a health care provider with respect to protected health information 45 CFR 164.512

44. Access of Individuals to Protected Health Information • Right of access includes access to PHI with • Health plan • Health care provider • Business partner if records not a duplicate • Access as long as records maintained 45 CFR 164.514

45. Accounting for Disclosures of Protected Health Information • Right to full accounting of disclosures from CEs except for treatment, payment and health care operations and for certain disclosures to health oversight or law enforcement agencies. • Right of accounting also applies to business partners 45 CFR 164.515

46. Right to Request Amendment or Correction • Requests will have to be either accepted or rejected within 60 days • Rejections will require an explanation in plain language • Patients can still file statement of disagreement - for the record 45 CFR 164.516

47. Administrative Requirements • Privacy officer • Training • Everyone likely to obtain access to PHI • Safeguards • Administrative, technical and physical safeguards to protect privacy • Complaint process 45 CFR 164.518

48. Documentation, Compliance and Enforcement • Documentation • Uses and disclosures • Individual rights • Administrative requirements • 6 years • Keep records of compliance activities, permit DHHS access and be nice! 45 CFR 164.520-522

49. Penalties & Claims • Civil penalties • Criminal penalties • No private cause of action • Third party beneficiary contract claims

50. Business Partners?