医疗卫生信息化环境下患者许可获取方案-美国

1、CONSUMER CONSENT OPTIONS FOR ELECTRONIC HEALTH INFORMATION EXCHANGE: POLICY CONSIDERATIONS AND ANALYSIS,PREPARED BY: Melissa M. Goldstein, JD Alison L. Rein, MS Associate Research Professor Director Department of Health Policy AcademyHealth School of Public Health and Health Services With Research A

2、ssistance From: Penelope P. Hughes Julie K. Lappas, JD Scott A. Weinstein Benjamin Williams,This paper is intended to:,Help identify issues and challenges associated with 5 core consent models for electronic health information exchange Provide basic definitions for the consumer consent discussion, a

3、nd point out sometimes divergent stakeholder perspectives Explore the consent models of a small set of electronic exchange efforts, and learn more about their rationale Consider and analyze some possible consequences associated with different consent approaches,This paper is NOT intended to:,Represe

4、nt a comprehensive analysis of the electronic health information exchange landscape Represent a comprehensive review of existing consent models as applied in active electronic exchange efforts Be directive or suggest “an answer”,What is covered,Definition of 5 core consent models Granularity and con

5、sent Select U.S. and International examples of exchange Analysis and impact of consent models Ethical considerations Process, logistical and technical considerations Legal framework Stakeholder perspectives,5 Basic Consent Models,No Consent Opt-out Opt-out with exceptions Opt-in Opt-in with restrict

6、ions,Granularity Observations,By Data Type: Few examples, but many exchanges currently have limited data available (e.g., lab tests only); many exchanges exclude sources of potentially-sensitive information By Provider: Some examples of sequestering data from specified provider organizations; fewer

7、by individual provider By Time Range: Rare, but evidenced in some specific use cases (e.g., emergency situations) By Purpose: Most only exchange information for treatment purposes; some for public health research and surveillance,Stakeholder Perspectives,Patients Want: Meaningful control over and pr

8、otection of their health information Quality, well-coordinated care Providers Want: To deliver quality, well-coordinated care Maximal quantity and quality (i.e., utility) of data Protection against liability Minimal administrative burden and cost Payers Want: Maximal patient and provider participati

9、on Minimal burden and cost Access to data Exchanges Want: Maximal patient and provider participation Maximal flexibility to sustain the exchange Minimal administrative / operational burden Maximal ability to provide value to participants,Primary Research,Phone and email correspondence HIT system dev

10、elopers (both for- and not-for-profit) State health agencies State-based HIT program managers Legal consultations,Secondary Research,Scholarly medical journals, e.g., JAMA, NEJM Scholarly legal journals, e.g., NYU Law Review, Journal of Law, Medicine guidance is needed for contextual assessments Helpful steps could include: Supporting collaboration across exchanges Compensatory measures to promote adoption / lessen short-term cost barriers Development of better evidence base to determine relative effectiveness and impact of different models Co