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