MDEpiNet Key Legal Questions

1. MDEpiNetKey Legal Questions Ralph F. Hall October 14, 2014

2. Background and Disclosures

3. Overview • Medical/scientific/clinical questions elicit the greatest attention • Legal structures needed to allow entity to succeed • As role of MDEpiNet changes, legal requirements change • Moving from an academic project changes requirements • External funding creates new challenges • Failure to address legal requirements threatens success

4. Overview • Objective is to identify, not resolve questions • Stakeholder concurrence vital • Requirements fall into four categories • Governance issues • Patient centric challenges • Regulatory matters • Other legal questions

5. Governance Questions • Who decides who manages the enterprise? • CEO and senior management • Succession • Board of Directors (or equivalent) • Can standard academic appointment processes meet the needs of a multi-stakeholder enterprise? • Accountability • Conflict of interest and role issues • Board and senior management • Funding sources • Agency involvement • Transparency

6. Patient Centric Questions • Informed consent • State law controls many informed consent requirements • Role of consent; when is it needed • Historically cannot consent to future or undisclosed research • “De-identification” may not solve consent requirements • Withdrawal of consent/opt out of research • Role of patient autonomy and patient centric medicine • Value proposition for patient • Children and geriatric patients • Family and cross-generational issues • Transparency and access to data

7. Patient Centric Questions • Return of research results • Should registry return research results to patient (or patient health care professional)? • Patient and system expectations • Is there any rational for not returning research results • Return of incidental findings • Patient and system expectation • Ability to unblind • Liability for failure to inform

8. Regulatory Issues • Use of registry data in pre-market context • Support for submissions • Role of controls, blinding, etc. • Consent requirements • Agency review (“bimo” inspections) • Use of registry data in post-market context • Formal post-market uses • 522 orders • Conditions of approval • General obligations • Adverse event reporting • CAPA systems

9. Regulatory Issues • Recalls and safety issues • Identification of issues • Obligation to assess data • May increase with roles in 522 and similar schema • Reporting to company • Reporting to agency • International obligations • Participating in recalls • Patient or HCP notification • Role in physician and hospital performance assessments • Role in payment and cost effectiveness decisions

10. Legal Issues • Fraud and abuse/antikickback issues • Attention from OIG • Sunshine Act reporting • Privacy issues • International differences • Role of registries in litigation • Discovery requests • “Pay to play” and FACA issues • IP rights • International use and issues • Transparency requirements • Interactions between registries

11. Conclusion and Questions Issue Identification Stakeholder Involvement Issue Resolution