The document discusses regulatory issues and opportunities in digital health beyond HIPAA. It summarizes that digital health infrastructure presents opportunities to improve healthcare delivery but also regulatory land mines to navigate, as various entities beyond HIPAA regulate health information use and new technologies. The document advocates a risk-based approach to health IT regulation to balance innovation and privacy protections.

1. Beyond HIPAA:
Digital Health Opportunities
and Regulatory Land Mines
David Harlow JD MPH
THE HARLOW GROUP LLC
blog • healthblawg.com
twitter • @healthblawg
Third Annual Central Massachusetts
Health Care Symposium
February 10, 2016

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We are challenged by
shifting sands

3. We Can Build a High-Performing
Digital Health Infrastructure

4. Consumer
Provider
Payor

6. Photo: Moyan Brenn via Flickr CC: https://flic.kr/p/baAt6e`

7. It’s not ALL about HIPAA

8. LabMD

9. I Know It When I See It
Photo: Ken Teegardin via Flickr CC https://flic.kr/p/9sbboc

10. FTC: Big Data
Is a Double-Edged Sword
Photo: vintagedept via Flickr CC https://flic.kr/p/7Ru3d7

11. Device Software
Regulated Unregulated

12. Risk-Based Framework
for Regulation of Health IT

14. hoto:HollyVictoriaNorvalviaFlickrCChttps://flic.kr/p/dFVZx5
Information Blocking

15. Heartbleed

16. State Rules on
Data Privacy
Including
“Sensitive”
Health Data

17. Many
State
Rules
Are
Stricter
Than
HIPAA

18. How Much Disruptive Innovation
Can a Regulated Industry
Handle?

19. Avoid Land Mines

21. The Inevitability of Digital Health

22. for contact info
txt dharlow to 50500
or scan the QR code
harlowgroup.net
healthblawg.com
twitter.com/healthblawg
david@harlowgroup.net
Thank You
David Harlow JD MPH
THE HARLOW GROUP LLC