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In




     Things That Go Bump In the Night
                           or
     Legal Issues that Frighten CMIOs
                 (or should)




              2012 Howard Burde Health Law LLC
Is




     Outline

     1.    Privacy and Security
     2.    Enforcement
     3.    Reimbursement/Meaningful Use
     4.    Mobile Technology/Information
     5.    Liability




           2012 Howard Burde Health Law LLC
>




    • Privacy and Security
            1.      HIPAA and HITECH
            2.      State Licensure Laws
            3.      State Condition Specific Laws




                 2012Howard Burde Health Law LLC
Privacy and Security Concerns for a CMIO

1. Privacy Policies

2. Compliance

3. Security/Technical Safeguards

4. Old Sources of PHI

5. New Technologies




       2012 Howard Burde Health Law LLC
•




    Privacy and Security Concerns

    Technical Safeguards
    •Access Controls                           •Audit Controls
    •Unique User Identification                •Integrity Controls
    •Emergency Access Procedure                •Authentication
    •Automatic Logoff                          •Transmission Security




                      2012Howard Burde Health Law LLC
Privacy and Security
Enforcement Concerns
     1.  Audits
         • OCR
              HITECH Mandate
              KPMG Contract
              Protocol
              Site Visit
              Audit Reports
              BAAs
         • Private
     2.  State Attorneys General
         •NAAG
         • OCR Training - Booz Allen Hamilton


                    2012 Howard Burde Health Law LLC
Enforcement

   Audits – Being Audit Ready

       Create and Maintain
            •Accurate Logs and Records
            •Comprehensive Compliance Program
            •(and) Compliance Program Description
            •Risk Management as Integrated Core
              Function




                 2012 Howard Burde Health Law LLC
Compliance Eco-Cycle

Risk Analysis   •            Risk Identification

Monitor and Verify
                             Counter Measure Remediation




                    2012 Howard Burde Health Law LLC
Reimbursement and Meaningful Use

       Fill In the Blank

       Our EHR’s got a screw loose
       Lab values it can’t always deduce
       Though our info sys techs
       Are breaking their necks
       We’ll never meet ______________!
       © American Health Lawyers Association




                                           2012Howard Burde Health Law LLC
•




    Going Mobile….
     (with apologies to The Who)

     Mobile Devices/Apps/ Information
        Creates new issues for CMIOs and Users
        •Privacy and Security
        •Licensure
        •Reimbursement
        •FDA
        •FCC
        • Liability
        Is the PHI part of the medical record
        or of the Legal Medical Record
                            2012 Howard Burde Health Law LLC
Liability for E-Health in a Mobile Health World

            Law School Primer
            Provider (Facility) Obligations
            Content
            Use (or Non-Use)




                   2012 Howard Burde Health Law LLC
Law School Primer – Professional Malpractice

           Injury/Adverse Event
           Standard of Care
           Causation
           Damages




              2012 Howard Burde Health Law LLC
Liability and Responsibility
   Provider/Facility Obligations:
        Content
        Accuracy
        Maintenance and Retention
        Production
        Destruction
                2012 Howard Burde Health Law LLC
Liability
     Duty of Accuracy
     - Provider Entry and Verification
          Details and Cut and Paste
     - Derivation
          Where did the PHI come from?
     - Audit Trail
          Who accessed it and When?
     - Correction and Addenda

                   2012 Howard Burde Health Law LLC
Maintenance, Retention and Destruction
Legal Requirements: Destruction/Spoliation
   What? Key Mobile Health Discussion
       Everything is Everywhere
       EHRs
       E-Mail
       Texts
       Tweets
       Apps
       Clouds
       Voice Mail
       Research Notes
            2012 Howard Burde Health Law LLC
•




    Liability in an E-Health World

       Who Can Be Liable?
       •Provider – Use or Disclosure of PHI, Data or
            Information
        •Provider/Facility – For use of or provision of
            decision support
        •Sources of PHI, Data or Decision Support
        •Static and Mobile Health Developers/Vendors



                     2012 Howard Burde Health Law LLC
•




    Liability
        For Adverse Events from Use or Non Use
        of Available PHI, Data or Information
             Issues:
                 •Presumption of Availability
                 •Quality/Accuracy/Integrity of Data
                 •Impact of False Claims
                 •Quality/Integrity of Data on Device
                 •Contributory Negligence


                     2012 Howard Burde Health Law LLC
Real Law!

   Cases on Consultation of Medical Record
   - Primus v. Galgano
   - Suniga v. Eyre
   - Susnis v. Radfar

   But, the Courts have moved on…
   - Chapa v. US
   - Hedgar v. Reliance
   Judicial Notice of Standard of Care to Access
   Available Information
                  2012 Howard Burde Health Law LLC
Liability in an E-Health and Mobile Health World
    Turns out to be the same as the rest of society

The Inexorable Progress of American Jurisprudence

             - T.J. Hooper
             - Das v. Thani
             - Shannon v. McNulty
             - Helling v. Carey
        Conundrum for CMIOs: How to meet and
        facilitate the Cheap, Easy and Accessible
        Standard?
                    2012 Howard Burde Health Law LLC
• Final Thoughts:
. Worry is Paying Interest on a Debt You Do Not Owe
    (Preparation and compliance beat worrying)

Finally, no matter what technology you implement or
enable,

▪ There is no App for Common Sense!

•   Illegitimi Non Carborundum


Questions? Gripes? Complaints?
                     2012 Howard Burde Health Law LLC
Howard A. Burde, Esquire, FHIMSS

    Howard@BurdeLaw.com
      www.BurdeLaw.com
        (c)215-292-1246
        (o)610-616-3357
 2320 Haverford Road, Suite 240
      Ardmore, PA 19003




           2012 Howard Burde Health Law LLC

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Presentation “Where the Rubber Meets the Road: Managing the Legal Challenges of Physicians in Informatics”

  • 1. In Things That Go Bump In the Night or Legal Issues that Frighten CMIOs (or should) 2012 Howard Burde Health Law LLC
  • 2. Is Outline 1. Privacy and Security 2. Enforcement 3. Reimbursement/Meaningful Use 4. Mobile Technology/Information 5. Liability 2012 Howard Burde Health Law LLC
  • 3. > • Privacy and Security 1. HIPAA and HITECH 2. State Licensure Laws 3. State Condition Specific Laws 2012Howard Burde Health Law LLC
  • 4. Privacy and Security Concerns for a CMIO 1. Privacy Policies 2. Compliance 3. Security/Technical Safeguards 4. Old Sources of PHI 5. New Technologies 2012 Howard Burde Health Law LLC
  • 5. Privacy and Security Concerns Technical Safeguards •Access Controls •Audit Controls •Unique User Identification •Integrity Controls •Emergency Access Procedure •Authentication •Automatic Logoff •Transmission Security 2012Howard Burde Health Law LLC
  • 6. Privacy and Security Enforcement Concerns 1. Audits • OCR HITECH Mandate KPMG Contract Protocol Site Visit Audit Reports BAAs • Private 2. State Attorneys General •NAAG • OCR Training - Booz Allen Hamilton 2012 Howard Burde Health Law LLC
  • 7. Enforcement Audits – Being Audit Ready Create and Maintain •Accurate Logs and Records •Comprehensive Compliance Program •(and) Compliance Program Description •Risk Management as Integrated Core Function 2012 Howard Burde Health Law LLC
  • 8. Compliance Eco-Cycle Risk Analysis • Risk Identification Monitor and Verify Counter Measure Remediation 2012 Howard Burde Health Law LLC
  • 9. Reimbursement and Meaningful Use Fill In the Blank Our EHR’s got a screw loose Lab values it can’t always deduce Though our info sys techs Are breaking their necks We’ll never meet ______________! © American Health Lawyers Association 2012Howard Burde Health Law LLC
  • 10. Going Mobile…. (with apologies to The Who) Mobile Devices/Apps/ Information Creates new issues for CMIOs and Users •Privacy and Security •Licensure •Reimbursement •FDA •FCC • Liability Is the PHI part of the medical record or of the Legal Medical Record 2012 Howard Burde Health Law LLC
  • 11. Liability for E-Health in a Mobile Health World Law School Primer Provider (Facility) Obligations Content Use (or Non-Use) 2012 Howard Burde Health Law LLC
  • 12. Law School Primer – Professional Malpractice Injury/Adverse Event Standard of Care Causation Damages 2012 Howard Burde Health Law LLC
  • 13. Liability and Responsibility Provider/Facility Obligations: Content Accuracy Maintenance and Retention Production Destruction 2012 Howard Burde Health Law LLC
  • 14. Liability Duty of Accuracy - Provider Entry and Verification Details and Cut and Paste - Derivation Where did the PHI come from? - Audit Trail Who accessed it and When? - Correction and Addenda 2012 Howard Burde Health Law LLC
  • 15. Maintenance, Retention and Destruction Legal Requirements: Destruction/Spoliation What? Key Mobile Health Discussion Everything is Everywhere EHRs E-Mail Texts Tweets Apps Clouds Voice Mail Research Notes 2012 Howard Burde Health Law LLC
  • 16. Liability in an E-Health World Who Can Be Liable? •Provider – Use or Disclosure of PHI, Data or Information •Provider/Facility – For use of or provision of decision support •Sources of PHI, Data or Decision Support •Static and Mobile Health Developers/Vendors 2012 Howard Burde Health Law LLC
  • 17. Liability For Adverse Events from Use or Non Use of Available PHI, Data or Information Issues: •Presumption of Availability •Quality/Accuracy/Integrity of Data •Impact of False Claims •Quality/Integrity of Data on Device •Contributory Negligence 2012 Howard Burde Health Law LLC
  • 18. Real Law! Cases on Consultation of Medical Record - Primus v. Galgano - Suniga v. Eyre - Susnis v. Radfar But, the Courts have moved on… - Chapa v. US - Hedgar v. Reliance Judicial Notice of Standard of Care to Access Available Information 2012 Howard Burde Health Law LLC
  • 19. Liability in an E-Health and Mobile Health World Turns out to be the same as the rest of society The Inexorable Progress of American Jurisprudence - T.J. Hooper - Das v. Thani - Shannon v. McNulty - Helling v. Carey Conundrum for CMIOs: How to meet and facilitate the Cheap, Easy and Accessible Standard? 2012 Howard Burde Health Law LLC
  • 20. • Final Thoughts: . Worry is Paying Interest on a Debt You Do Not Owe (Preparation and compliance beat worrying) Finally, no matter what technology you implement or enable, ▪ There is no App for Common Sense! • Illegitimi Non Carborundum Questions? Gripes? Complaints? 2012 Howard Burde Health Law LLC
  • 21. Howard A. Burde, Esquire, FHIMSS Howard@BurdeLaw.com www.BurdeLaw.com (c)215-292-1246 (o)610-616-3357 2320 Haverford Road, Suite 240 Ardmore, PA 19003 2012 Howard Burde Health Law LLC