Ralph F. Hall

October 14, 2014

Background and Disclosures

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OverviewMedical/scientific/clinical questions elicit the

greatest attentionLegal structures needed to allow entity to succeedAs 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

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OverviewObjective is to identify, not resolve

questions─ Stakeholder concurrence vital

Requirements fall into four categories

1.Governance issues

2.Patient centric challenges

3.Regulatory matters

4.Other legal questions

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Governance QuestionsWho 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

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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 issuesTransparency and access to data

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Patient Centric QuestionsReturn 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

resultsReturn of incidental findings─ Patient and system expectation

Ability to unblindLiability for failure to inform

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Regulatory IssuesUse 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

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Regulatory IssuesRecalls 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 assessmentsRole in payment and cost effectiveness decisions

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Legal IssuesFraud and abuse/antikickback issues─ Attention from OIG

Sunshine Act reportingPrivacy issues─ International differences

Role of registries in litigation─ Discovery requests

“Pay to play” and FACA issuesIP rightsInternational use and issuesTransparency requirementsInteractions between registries

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Conclusion and Questions

Issue Identification

Stakeholder Involvement

Issue Resolution

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