The Perfect Storm: Challenges on the Horizon for Funding and Regulatory Controls in Research Andrew Nelson Executive Director HealthPartners Research Foundation

2 Compression Forces  External Factors  Internal Reactions  Storm Forecasting

3 HealthPartners  Clinic system consisting of 30 clinics and 600 physicians  Largest hospitals in the Twin Cities, Regions Hospital.  9,200 employees, the vast majority of which are care providers  Health plan with 675,000 members.  MN networks with over 11,000 physicians  Open access and care system network models  National network capability  Insured and self-insured products  HealthPartners Research Foundation, Institute for Medical Education, and are founding members of the Institute for Clinical Systems

4 HealthPartners Research Foundation  Over 200 active studies  13 Million Dollar Budget in 2005  Research staff of 100, 27 research investigators  One of the founding member of the HMO Research Network  92% externally funded  Strategic focus: Integration of Research and Practice

5 External Factors - Dramatic Changes  Use of data, data bases and health information technologies  Financing of health care  Quality and tolerance  Trust in research  Research discoveries – genomics and other wonders

6 External Factors - Dramatic Changes cont.  IOM Responsible Research, 2003  Privacy concerns and regulatory responses  Research funding flat/declining  Legislating & political influencing science  Public access to research and health plan data  Translating research into practice

7 Privacy Concerns and Regulatory Responses  HIPAA privacy and security  Gramm-Leach-Blieley  Common Rule  FDA  State Law  Institutional compliance and risk management

8 HPRF Response  Upswing in proposal development  Staff restructuring and organizational consolidated  Investigator roles and expectations evolving  Finance and compliance controls continuously expanding

9 HPRF Response Cont.  “Integrating research and practice” strategic direction evolving into “Optimizing Practice Through Research”  Increasing collaborations and research networks  Synergy within and value to HealthPartners  Creating research technology transfer opportunities  Expanded health information technology research agenda

10 Storm Forecast  Storm will become norm  Value proposition for research increasingly challenged  Nature of research will focus on utility and effectiveness  Open data bases  Risk adversity increasing  Compliance burden increasing