Abstract
This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency.
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Notes
For example, at the Web site of a leading DTC company, 23andME, a consumer may order a test online. The company then sends a test kit, which the consumer returns with a saliva sample. The company’s laboratory performs the test on DNA extracted from the sample and then makes the results available to the consumer on a secure Web site. The results include genomic data and health-related information about disease carrier status, disease risk, and personalized response to medications See 23andME (2012).
Regulatory concerns have already generated significant regulatory action in some U.S. states and in some other nations. For example, in 2008, New York and California sent “cease and desist” letters to several DTC companies asserting that they must obtain state licenses to do business; some companies obtained licenses, others ceased doing business in these states (Vorhaus 2010a). Some states, including Connecticut and Massachusetts, require that genetic tests be ordered by physicians (Borry et al. 2010, p. 103). For a discussion of the international regulatory situation, see Borry et al. 2010, pp. 104–105; Vorhaus 2011a.
Vorhaus (2010a) suggests that, during this early period of development of DTC genetic testing, while CMS presumably had authority to regulate the laboratories of DTC companies under CLIA, it was unclear whether CMS intended to enforce CLIA regulations on DTC laboratories. Also, while FDA had discretionary authority to regulate DTC genetic tests as a form of LDT, it was unclear whether FDA would exercise this discretion.
The facts of the case were related by the court as the “pathetic story of physical and mental abuse of a hapless girl in a Government-run Institute.” See Chandigarh Administration vs. Unknown (2009), p. 2.
From India’s Medical Termination of Pregnancy Act (1971), quoted in Suchita Srivastava & ANR. vs. Chandigarh Administration (2009), pp. 5–6.
See, for example, Shukla (2009).
See for example, Cohen (2009).
For CLAS Standards, see Appendix A, from Department of Health & Human Services, Office of Minority Health (2012a).
Medical champion is a term employed by medical-legal partnerships to describe the physician or physicians serving in a capacity similar to medical director and who agree to support and promote collaboration between legal and healthcare professionals.
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Acknowledgments
Roberta M. Berry wishes to acknowledge the excellent research assistance on DTC genetic testing of Hillary Alberta and Sarah Chambers.
The co-authors, whose names are listed in alphabetical order, are academic affiliates of the Georgia State University Center for Law, Health & Society and thank the Center for its support. The Center http://law.gsu.edu/clhs/ engages in interdisciplinary research, education, and community outreach to prepare future leaders in the legal and health professions.
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Appendices
Appendix
U.S. Department of Health and Human Services Office of Minority Health.
National Standards on Culturally and Linguistically Appropriate Services (CLAS).
Standard 1
Health care organizations should ensure that patients/consumers receive from all staff member’s effective, understandable, and respectful care that is provided in a manner compatible with their cultural health beliefs and practices and preferred language.
Standard 2
Health care organizations should implement strategies to recruit, retain, and promote at all levels of the organization a diverse staff and leadership that are representative of the demographic characteristics of the service area.
Standard 3
Health care organizations should ensure that staff at all levels and across all disciplines receive ongoing education and training in culturally and linguistically appropriate service delivery.
Standard 4
Health care organizations must offer and provide language assistance services, including bilingual staff and interpreter services, at no cost to each patient/consumer with limited English proficiency at all points of contact, in a timely manner during all hours of operation.
Standard 5
Health care organizations must provide to patients/consumers in their preferred language both verbal offers and written notices informing them of their right to receive language assistance services.
Standard 6
Health care organizations must assure the competence of language assistance provided to limited English proficient patients/consumers by interpreters and bilingual staff. Family and friends should not be used to provide interpretation services (except on request by the patient/consumer).
Standard 7
Health care organizations must make available easily understood patient-related materials and post signage in the languages of the commonly encountered groups and/or groups represented in the service area.
Standard 8
Health care organizations should develop, implement, and promote a written strategic plan that outlines clear goals, policies, operational plans, and management accountability/oversight mechanisms to provide culturally and linguistically appropriate services.
Standard 9
Health care organizations should conduct initial and ongoing organizational self-assessments of CLAS-related activities and are encouraged to integrate cultural and linguistic competence-related measures into their internal audits, performance improvement programs, patient satisfaction assessments, and outcomes-based evaluations.
Standard 10
Health care organizations should ensure that data on the individual patient’s/consumer’s race, ethnicity, and spoken and written language are collected in health records, integrated into the organization’s management information systems, and periodically updated.
Standard 11
Health care organizations should maintain a current demographic, cultural, and epidemiological profile of the community as well as a needs assessment to accurately plan for and implement services that respond to the cultural and linguistic characteristics of the service area.
Standard 12
Health care organizations should develop participatory, collaborative partnerships with communities and utilize a variety of formal and informal mechanisms to facilitate community and patient/consumer involvement in designing and implementing CLAS-related activities.
Standard 13
Health care organizations should ensure that conflict and grievance resolution processes are culturally and linguistically sensitive and capable of identifying, preventing, and resolving cross-cultural conflicts or complaints by patients/consumers.
Standard 14
Health care organizations are encouraged to regularly make available to the public information about their progress and successful innovations in implementing the CLAS standards and to provide public notice in their communities about the availability of this information.
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Berry, R.M., Bliss, L., Caley, S. et al. Recent Developments in Health Care Law: Culture and Controversy. HEC Forum 25, 1–24 (2013). https://doi.org/10.1007/s10730-012-9203-z
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DOI: https://doi.org/10.1007/s10730-012-9203-z