1. Advanced HIPAA Issues for Biotech and Life Sciences Companies: Mark E. Schreiber Palmer & Dodge LLP 111 Huntington Avenue Boston, MA 02199 617-239-0585 mschreiber@palmerdodge.com April 8, 2005 On the Frontier of Science and On the Edge of HIPAA

2. 2 HIPAA Provisions under which Biotech / Life Sciences Issues Arise n HIPAA provider coverage? n Business Associate applicability? n Authorizations – unspecified research n Research data bases n Accounting for research disclosures n Clinical studies in E.U. – HIPAA interface

3. 3 Medical Device / Testing Companies – Covered Entities? n May be “health care provider” under broad HIPAA definition n Most don’t engage in electronic standard transactions n Some may unwittingly send claims, insurance or related e-mails n If so, possible HIPAA coverage n Not all ask right questions of right people l To properly determine status If covered, then what? n Privacy notices, etc. n To whom?

4. 4 Are Clinical Researchers / Sponsors or CRO’s Business Associates? n Generally “research” not a BA function performed for covered entities n “We’re not a BA” letter n BA’s often negotiated l Business clout n If researcher / sponsor also provides l Quality assurance, or l Data processing services for covered entity u De-identifying records, or u Creating limited data sets l Then researcher / sponsor is BA n Researcher / sponsor – document in CTA that no BA-triggering services provided

5. 5 Sponsors Generally Not Covered Entity or BA No HIPAA concerns, then, right? Not so fast... n Sites will and should impose handling restrictions in CTA’s n Some sites impose informed consent confidentiality limitations l Blending with HIPAA standards, on researchers / sponsors and “downstream” l Restricts marketing use

6. 6 Sponsors Generally Not Covered Entity or BA n Confidentiality agreement OK, but modify agreements l To specifically allow u For monitoring services, and u Other purposes in HIPAA-compliant patient authorization n Other agreement “pass-throughs” l Reps and warrantees, indemnity language n Researchers / sponsors – rigorous privacy policies / practices that approximate those of HIPAA l HIPAA treated as de facto standard of care u State law invasion of privacy claims

7. 7 Authorizations – Future Unspecified Research n HIPAA authorizations for research l Can broadly cover patient’s entire medical record l Can broadly cover classes or persons to whom and by whom PHI can be used / disclosed l Under “purpose” element, u “Each purpose” must be specified u Valid authorization for unspecified studies s Virtually impossible under HIPAA s Registry or database for unspecified future research – OK

8. 8 Research Databases under HIPAA n Database – separate purpose from primary protocol n Must be specifically authorized l In protocol authorization or l In separate subsequent authorization n If database maintained by covered entity l Future disclosures must be pursuant to new authorization n If database disclosed to sponsor l Generally outside HIPAA

9. 9 IRB Waivers and Future Researcher Follow Up with Participants If IRB Waiver n Researcher free to use PHI for current research n New, specific waiver necessary l Before researcher can contact study participants about new study

10. 10 Accounting for Research Disclosures n NEED NOT be accounted for where l Disclosed under authorization l Disclosed in limited data set form u Needs data use agreement n MUST be accounted for upon individual request where disclosed pursuant to IRB waiver n Less detailed accounting: Where covered entity discloses records of  50 individuals under IRB waiver during requested accounting period

11. 11 Coming HIPAA Attractions: Clinical Studies Abroad and Outsourcing E.U. Model different – no HIPAA statute but broader data laws n E.U. Data Protection laws l Each E.U. country n Consent necessary for medical data use (sensitive data) l Specific use, purpose, etc. l English or in local language? n Data transfer out of E.U. country to U.S. l Consent to transfer – different from consent to use / collect l Data protection model clauses / agreements l U.S. Safe Harbor

12. 12 Who Follows Up on E.U. Branch Office or E.U. Consents? n Some companies not aware of or abide by these laws n Risk to studies? n Sometimes requires explanation of importance n E.U. clinical directive Is foreign medical PHI subject to HIPAA when transferred to U.S. HIPAA covered entity? n Telemedicine n Medical records of E.U. resident sent to U.S.

13. 13 Outsourcing of HIPAA Data Processing Overseas n Canada, India, Pakistan, Philippines n Medical transcription services n Pakistan case – multiple contractors to HIPAA covered entity n Rep. Markey letter to HHS n Possible outsourcing amendments to HIPAA