Where Did HIPAA Come From? “HIPAA Then and Now”

2. Where Did HIPAA Come From?“HIPAA Then and Now” Peter Swire Georgia Tech Scheller College of Business Alston & Bird LLPIAPP-Las Vegas 2015

3. Overview • Where did the HIPAA statute and regulation come from? • Why was its scope focused only on health care providers and insurers? • What were the trade-offs between data use and privacy in the original regulation? • Why is HIPAA starting to seem outdated today?

4. Origins of Health Insurance Portability and Accountability Act of 1996 • 1996 Kennedy-Kassenbaum bill, to enable those with pre-existing conditions to keep health insurance. • “Portability” • Industry concern – that’s a burden! So, include “administrative simplification” – standardized, electronic payments from the feds. • Privacy concern – wait, electronic records and no privacy or security rules for health data! So, tell HHS to create regs if Congress doesn’t act by 1999. • The story as of 2003 at http://peterswire.net/medical-privacy/

5. HIPAA Privacy Rule • Surprise! Congress couldn’t even get a privacy bill out of subcommittee. • Proposed Privacy Rule 1999, 53,000 public comments • Final Privacy Rule 2000 • President Bush enters 2001, decides to keep the Rule, with modest changes in 2002 • Compliance soon after • 2009 Recovery Act • HI-Tech: Enforcement powers clearer, including for business associates • Meaningful Use incentives mean (finally) shift to provider electronic records

6. The Scope of HIPAA • The most important aspect of a regulatory regime: who/what is covered • If not covered, then you don’t care about all of those super-detailed rules and compliance problems • HIPAA had “administrative simplification” for providers and insurers who received payments from the US for Medicare, Medicaid, etc. • Therefore, if you are not part of that payments system, then no HIPAA requirements • E.g., any website or health app is outside the scope, unless it is part of a covered entity

7. Dual Purposes of HIPAA • Data flows are essential to good health care, so don’t need patient consent for: • Treatment, Payment, and Health Care Operations • Medical research (if IRBs, de-identification, limited data set) • Other public purposes (required by law, court order, etc.) • Privacy is essential for patient trust and accurate interactions with medical personnel: • Psychotherapy notes • And, in general

8. Fair Information Privacy Principles in HIPAA • Notice • Opt-in consent as baseline • Access and accounting • Data security • Minimum necessary • Accountability/enforcement

9. Conclusion • In 1996, dominant holders of medical information were providers and insurers • HIPAA didn’t cover a book store that sold readings about cancer – should it apply to web sites and apps today? • Today, health care Big Data increasingly outside of the covered entities • In 1996, the alternative to HIPAA was to have no national health privacy rules, even as the health payment system became national and electronic • Today, HIPAA is well established in the covered entities • But, as our panel will discuss, covered entities are becoming a much smaller share of the data universe …