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HITECH: Three Years
Later
Linda D. Koontz
Alison R. Brunelle

      Tuesday, April 3, 2012 | Track 2 | 3:45 PM to 4:15 PM




                For Interconnected Health 2012                © 2012 The MITRE Corporation. All rights reserved.
HIPAA Then and Now:
What Has HITECH Changed?


    Breach                                          Business
    Notification                                    Associate Liability


    Enhanced Privacy
                                                    Audit Programs
    and Security


                   Enforcement
                   Actions


                                                                                                 Page 2

                   For Interconnected Health 2012           © 2012 The MITRE Corporation. All rights reserved.
HITECH Timeline of Events

                            Management
                              Services
                            Organization
                          (“MSO”) agrees
                            to settle for
                              potential                  "Meaningful                                        Funding
                           HIPAA privacy                                                 We are
                                                             Use"                                        opportunities
  Passage of                and security                requirement in                    here            projected to
    ARRA                   rule violations                  effect                                            end



        2009                        2010                        2011                        2012               2015




                            Grant awards                Cignet Health                   HHS
                              to states                   faces first                anticipates
                            commences                       HIPAA                  completing 150
                                                        penalties for               audits by the
                                                           violating                 end of 2012
                                                        Privacy Rule




Source: Adapted from Minnesota e-Health Initiative Public Meeting on the HITECH ACT on March 18, 2009.
                                                                                                                                                 Page 3

                                                       For Interconnected Health 2012                       © 2012 The MITRE Corporation. All rights reserved.
Meaningful Use: Privacy Considerations
    Capture and




                    Stage 1
    Share Data
    • Electronic
                              Decision




                                                     Proposed Stage 2
      copies of
      protected               Support
      health                  Care
      information
                              • Certified EHR
                                                                        Outcomes




                                                                                                 TBD Stage 3
      (PHI) to
      patients                  adoption with                           • Systems
    • Secure                    all clinical                              interoperability
      messaging                 information                             • Access to
                                documented                                comprehensive
                              • Health                                    patient data
                                information                               from all
                                exchange                                  available
                              • Patient                                   sources
                                engagement                              • Advanced
                                                                          patient
                                                                          engagement




                                                                                                                           Page 4

                              For Interconnected Health 2012                          © 2012 The MITRE Corporation. All rights reserved.
Backup


                                                                               Page 5

         For Interconnected Health 2012   © 2012 The MITRE Corporation. All rights reserved.
HIPAA 101: What Information Is Protected?


                                                                                                              Rule
Protected Health Information (PHI)
                                                                                                                                                                                    Law

All "individually identifiable health information” (IIHI)
• Held or transmitted by a covered entity or its business associate, in
  any form or media, whether electronic, paper, or oral.
• Excludes from PHI employment records that a covered entity
  maintains in its capacity as an employer and education and certain
  other records subject to, or defined in, the Family Educational
  Rights and Privacy Act.
                                                                                                      Two
De-Identified Health Information                                                                      Ways


• There are no restrictions on the use or disclosure of de-identified
  health information.
 Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Privacy Rule.
                                                                                                                                                                    Page 6

                                                            For Interconnected Health 2012                                     © 2012 The MITRE Corporation. All rights reserved.
HIPAA 101: Core Concepts

                                                                     • Title I of HIPAA protects health
                                                                       insurance coverage for workers and
                                                                       their families when they change or
                                                                       lose their jobs.
                                                                     • Title II of HIPAA, known as the
                                                                       Administrative Simplification (AS)
Health Insurance                                                       provisions, requires the
                                                                       establishment of national standards
 Portability and                                                       for electronic health care transactions
                                                                       and national identifiers for providers,
 Accountability                                                        health insurance plans, and
(HIPAA) of 1996                                                        employers.




Source: Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (1996), (codified in scattered sections of title 42 U.S. Code); 45 C.F.R. parts
160 and 164 (HIPAA Privacy and Security Rules).
                                                                                                                                                                         Page 7

                                                              For Interconnected Health 2012                                        © 2012 The MITRE Corporation. All rights reserved.
HIPAA 101: The Privacy Rule
                           • Establishes national standards to protect individuals’ medical
                             records and other personal health information and applies to health
   Openness and
                             plans, health care clearinghouses, and those health care providers
   Transparency,             that conduct certain health care transactions electronically.
   Accountability




                           • Requires appropriate safeguards to protect the privacy of personal
                             health information, and sets limits and conditions on the uses and
    Safeguards,
                             disclosures that may be made of such information without patient
Collection, Use, and         authorization.
Disclosure Limitation




                           • Gives patients rights over their health information, including rights
                             to examine and obtain a copy of their health records, and to request
Individual Access and        corrections.
  Choice, Correction




  Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Privacy Rule.
                                                                                                                                                                     Page 8

                                                             For Interconnected Health 2012                                     © 2012 The MITRE Corporation. All rights reserved.
HIPAA 101: The Security Rule
               • Establishes national standards to
                 protect individuals’ electronic personal
                 health information that is created,
                 received, used, or maintained by a
Accountability
                 Covered Entity.



                                      • Requires appropriate administrative,
                                        physical and technical safeguards to
                                        ensure the confidentiality, integrity, and
 Safeguards,                            security of electronic protected health
 Data Quality
 and Integrity                          information.



Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Security Rule.
                                                                                                                                                                    Page 9

                                                           For Interconnected Health 2012                                      © 2012 The MITRE Corporation. All rights reserved.
HIPAA 101: The Enforcement Rule

                                                                 • Contains provisions
                                                                   relating to compliance
                                                                   and investigations, the
                                                                   imposition of civil money
                                                                   penalties for violations of
                                                                   the HIPAA Administrative
Accountability                                                     Simplification Rules, and
                                                                   procedures for hearings.




Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Enforcement Rule.
                                                                                                                                                              Page 10

                                                          For Interconnected Health 2012                                   © 2012 The MITRE Corporation. All rights reserved.
HITECH 101: Core Concepts

                                                                • Enacted as part of the American Recovery and
                                                                  Reinvestment Act (ARRA) of 2009, is designed to
                                                                  promote the widespread adoption and
                                                                  standardization of health information technology.
                                                                • Requires the Department of Health and Human
                                                                  Services (HHS) to modify the HIPAA Privacy,
                                                                  Security, and Enforcement Rules to strengthen
 Health Information                                               the privacy and security protections for health
                                                                  information and to improve the workability and
   Technology for                                                 effectiveness of the HIPAA Rules.
                                                                • Mandated the Office of the National Coordinator
   Economic and                                                   for Health Information Technology (ONC)
   Clinical Health                                                originally created under an Executive Order in
                                                                  2004.
(HITECH) Act of 2009




Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Breach Notification Rule.
                                                                                                                                                                Page 11

                                                           For Interconnected Health 2012                                    © 2012 The MITRE Corporation. All rights reserved.
HITECH 101: The Breach Notification Rule
              • Establishes an expansive protocol requiring
                HIPAA Covered Entities and their Business
                Associates to provide notice when an
Openness and    individual's “unsecured” protected health
Transparency,   information has been breached.
Accountability




                                      • Requires appropriate breach notification
                                        must be provided to individuals, HHS, and/or
                                        the media depending on the circumstances.
Accountability




Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Breach Notification Rule.
                                                                                                                                                                Page 12

                                                           For Interconnected Health 2012                                    © 2012 The MITRE Corporation. All rights reserved.

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Interconnected Health 2012 Hitech 3 Years Later

  • 1. HITECH: Three Years Later Linda D. Koontz Alison R. Brunelle Tuesday, April 3, 2012 | Track 2 | 3:45 PM to 4:15 PM For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 2. HIPAA Then and Now: What Has HITECH Changed? Breach Business Notification Associate Liability Enhanced Privacy Audit Programs and Security Enforcement Actions Page 2 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 3. HITECH Timeline of Events Management Services Organization (“MSO”) agrees to settle for potential "Meaningful Funding HIPAA privacy We are Use" opportunities Passage of and security requirement in here projected to ARRA rule violations effect end 2009 2010 2011 2012 2015 Grant awards Cignet Health HHS to states faces first anticipates commences HIPAA completing 150 penalties for audits by the violating end of 2012 Privacy Rule Source: Adapted from Minnesota e-Health Initiative Public Meeting on the HITECH ACT on March 18, 2009. Page 3 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 4. Meaningful Use: Privacy Considerations Capture and Stage 1 Share Data • Electronic Decision Proposed Stage 2 copies of protected Support health Care information • Certified EHR Outcomes TBD Stage 3 (PHI) to patients adoption with • Systems • Secure all clinical interoperability messaging information • Access to documented comprehensive • Health patient data information from all exchange available • Patient sources engagement • Advanced patient engagement Page 4 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 5. Backup Page 5 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 6. HIPAA 101: What Information Is Protected? Rule Protected Health Information (PHI) Law All "individually identifiable health information” (IIHI) • Held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. • Excludes from PHI employment records that a covered entity maintains in its capacity as an employer and education and certain other records subject to, or defined in, the Family Educational Rights and Privacy Act. Two De-Identified Health Information Ways • There are no restrictions on the use or disclosure of de-identified health information. Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Privacy Rule. Page 6 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 7. HIPAA 101: Core Concepts • Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose their jobs. • Title II of HIPAA, known as the Administrative Simplification (AS) Health Insurance provisions, requires the establishment of national standards Portability and for electronic health care transactions and national identifiers for providers, Accountability health insurance plans, and (HIPAA) of 1996 employers. Source: Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (1996), (codified in scattered sections of title 42 U.S. Code); 45 C.F.R. parts 160 and 164 (HIPAA Privacy and Security Rules). Page 7 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 8. HIPAA 101: The Privacy Rule • Establishes national standards to protect individuals’ medical records and other personal health information and applies to health Openness and plans, health care clearinghouses, and those health care providers Transparency, that conduct certain health care transactions electronically. Accountability • Requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and Safeguards, disclosures that may be made of such information without patient Collection, Use, and authorization. Disclosure Limitation • Gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request Individual Access and corrections. Choice, Correction Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Privacy Rule. Page 8 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 9. HIPAA 101: The Security Rule • Establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a Accountability Covered Entity. • Requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and Safeguards, security of electronic protected health Data Quality and Integrity information. Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Security Rule. Page 9 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 10. HIPAA 101: The Enforcement Rule • Contains provisions relating to compliance and investigations, the imposition of civil money penalties for violations of the HIPAA Administrative Accountability Simplification Rules, and procedures for hearings. Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Enforcement Rule. Page 10 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 11. HITECH 101: Core Concepts • Enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009, is designed to promote the widespread adoption and standardization of health information technology. • Requires the Department of Health and Human Services (HHS) to modify the HIPAA Privacy, Security, and Enforcement Rules to strengthen Health Information the privacy and security protections for health information and to improve the workability and Technology for effectiveness of the HIPAA Rules. • Mandated the Office of the National Coordinator Economic and for Health Information Technology (ONC) Clinical Health originally created under an Executive Order in 2004. (HITECH) Act of 2009 Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Breach Notification Rule. Page 11 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.
  • 12. HITECH 101: The Breach Notification Rule • Establishes an expansive protocol requiring HIPAA Covered Entities and their Business Associates to provide notice when an Openness and individual's “unsecured” protected health Transparency, information has been breached. Accountability • Requires appropriate breach notification must be provided to individuals, HHS, and/or the media depending on the circumstances. Accountability Source: U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) , Website, The HIPAA Breach Notification Rule. Page 12 For Interconnected Health 2012 © 2012 The MITRE Corporation. All rights reserved.