11/12/2013 Precision Medicine and Personalized Medicine Setting the stage: Privacy, security, regulation, and voluntary data sharing within Precision Medicine UCSF Mini-Medical School November 7, 2013 Claire D. Brindis, Dr. P.H. Director, Philip R. Lee Institute for Health Policy Studies Professor, Pediatrics and Health Policy Building a laye re d kno wle dge ne two rk: I nte rlaye r c o nne c tio ns e stablishe d by multidisc iplinary te ams UCSF Precision Medicine Platform Patient Medic al R ec or d (exper ience, behavior , etc.) E pidemiolo gy E nviro nme nt Mic r o bio me Me tabo lo me Pro teo me Ge no me • 1
11/12/2013 UCSF Precision Medicine Platform Ability to Integrate practices and policies across three planes Ability to Integrate practices and policies across three planes Consumer Engagement Regulatory Transdisciplinary science: Transdisciplinary science: Merge physics/chemistry/engineering/ Merge physics/chemistry/engineering/ Privacy Computation theory, concepts, methods Computation theory, concepts, methods into biomedical research into biomedical research Security Biomedical continuum: Biomedical continuum: Data Build seamless links between basic Build seamless links between basic Sharing discovery, translation, clinical care, discovery, translation, clinical care, patients, citizens patients, citizens Stakeholder synergy: Stakeholder synergy: Cooperate across .edu, .com, .org Cooperate across .edu, .com, .org and .gov sectors and others and .gov sectors and others Stakeholders Stakeholders Geo-environmental, weather patterns, etc. EMRs, diagnostic images Claims, revenue cycle Purchasing patterns, Clinical trials, genomics social media 7 Table of Contents 2
11/12/2013 Chinese Symbol for Change 变 变 Danger and Opportunity From here to tomorrow: The Promise of Precision Medicine What system infrastructure will be necessary? What health care systems will need to be in place to provide precision and personalized medicine? Along the continuum of health and illness, how could precision medicine be integrated? What will it take to create such a system? 3
11/12/2013 Challenges in Implementation of Challenges in Implementation of Precision Medicine Precision Medicine 1. Derive new insights from complex and large data sets. 2. “$1,000 genome” -- Sequencing an individual’s or a tumor’s entire genome 1. Capacity to interpret genomic can occur relatively inexpensively and sequence data? can be offered as part of clinical care. What genetic variants are ready for Downstream interpretation will likely “translation with impact” on add significant costs (at least in the sufficiently large proportion of short term). population? Challenges in Implementation of Challenges in Implementation of Precision Medicine Precision Medicine 3. Are technological advances 5. Regulatory issues - Examples outpacing our ability to use FDA Drug Approval information effectively? Linking data from patient care with data from research. Precision Medicine needs to have 4. Are we as a society ready to make these identifiable data vs. basic and types of investments? Disparities? translational research use de-identified or unidentifiable data. Institutional Review Board requirements 4
11/12/2013 Challenges in Implementation of Challenges in Implementation of Precision Medicine Precision Medicine 6. Determining Coverage and Reimbursement – 7. Patient Confidentiality and Consent -- Molecular testing codes -- Reimbursement concerns for patients -- Unclear value for payers Challenges in Implementation of Learning From the Past….. Precision Medicine 8. System Capacity • Maintaining confidentiality and protection of data • Standardized risk assessment tools • Integration of family health history into EMR • Develop capabilities (consent, interpretation, counseling) for solving diagnostic dilemmas • Developing clinical decision support tools for pharmacogenomics and diagnostic tests 5
11/12/2013 Challenges in Implementation of Challenges in Implementation of Precision Medicine – Precision Medicine 9. Intersection with Population Health? 8. System Capacity (more…. • Develop the policy agenda to support PPM • Assess genomic medicine literacy of patients and providers • Education for the next generation of providers and health care workforce Value • Active engagement of patients and their families In the meantime…. Forecasting 6
11/12/2013 The Opportunity for Genom e I nform ed Medical Care Susceptibility Screening Diagnosis Prognosis Treatment Prediction is always difficult, Disease Burden especially about the future Cost Niels Bohr Time Baseline Preclinical Clinical Disease Risk Progression and Progression Ginsburg GS and Willard H Genomic and Personalized Medicine . Academic Press: 2012. Questions in establishing a personal data value Personal data value chain chain The individual The individual Establish Processing Establish Processing Data Collection Label Storage Label Label Dissemination Label Label Label Collection Storage Dissemination and analysis Compatibility and analysis Compatibility • Who is the • Where is the • How is the • Who is the data collecting data being data being being shared • Personal • Storage • Purpose of • Dissemination party? stored? processed? with? data could protections analysis could could include • What type of • What policies • At what level • Is it a different be collected may be change from transfer to entity are are in place in of analysis? organization or from the different originally different entities they? the storage entity? individual in stated or types of • In combination • Storage location • What is the with what • For what either a purpose entities Illustrative location purpose for • For how long? other data purpose? passive or could be in * Intent of • Levels of question set which they sets? active • What are the • In what different analysis and protection and are manner protection • For what location? sovereign degree of protection collecting • Collection of methods purpose? states anonymization) capacity can data? • What security data may be (including could change vary between • For whose mechanisms • Storage • What type technical and transferred parties benefit? govern the period can and format organizational? to multiple transfer? vary from • Different is the data? stakeholders original purpose/use/ intent level of analysis 7
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