The Physician-Patient Relationship and a National Health Information Network

American Recovery and Reinvestment Act § 9202(a)(1) (2009).

See, e.g., Hall M. A. Dugan E. Zheng B. , and Mishra A. K. , “Trust in Physicians and Medical Institutions: What Is It, Can It Be Measured, and Does It Matter?” Milbank Quarterly 79, no. 4 (2001): 613–639.

See Lee Y.-Y. Lin J. L. , “The Effects of Trust in Physician on Self-Efficacy, Adherence and Diabetes Outcomes,” Social Science & Medicine 68, no. 6 (2009): 1060–1068. There is evidence that this may be mediated by race; see, e.g., Nguyen G. C. Laveist T. A. Harris M. L. Datta L. W. Bayless T. M. , and Brant S. R. , “Patient Trust-in-Physician and Race Are Predictors of Adherence to Medical Management in Inflammatory Bowel Disease,” Inflammatory Bowel Disease 15, no. 8 (2009): 1233–1239. There is also evidence that this may be mediated by high costs of care; see Cunningham P. J. , “High Medical Cost Burdens, Patient Trust, and Perceived Quality of Care,” Journal of General Internal Medicine 24, no. 3 (2009): 415–20.

See, e.g., Beauchamp T. L. Childress J. F. , Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001): at 312–319.

Emanuel E. J. Emanuel L. L. , “Four Models of the Physician-Patient Relationship,” JAMA 267, no. 16 (1992): 2221–2226, at 2222.

Brody H. , “Transparency: Informed Consent in Primary Care,” Hastings Center Report 19, no. 5 (1989): 5–9.

E.g., Brody H. , Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Lanham, Md.: Rowman & Littlefield, 2007): at 3.

See, e.g., Julliard K. , “What Latina Patients Don't Tell Their Doctors,” Annals of Family Medicine 6 (2008): 243–249.

Miller J. , “The Other Side of Trust in Health Care: Prescribing Drugs with the Potential for Abuse,” Bioethics 21, no. 1 (2007): 51–60.

Trescot A. M. Helm S. Hansen H. Benyamin R. Glaser S. E. Adlaka R. Patel S. , and Manchikanti L. , “Opioids in the Management of Chronic Non-Cancer Pain: An Update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines,” Pain Physician, Opioids Special Issue 11, no. 2 suppl. (2008): S5–S62.

AMA Opinion 7.03 requires retention or transfer of records that may be of value to the patient, even after physician retirement, available at <http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion703.shtml> (last visited November 23, 2009).

Baier A. , “Trust and Antitrust,” Ethics 96, no. 2 (1986): 231–260. A central goal of Baier's paper was to criticize exclusive reliance on contract as a model for human relationships.

See Hall , supra note 2, at 616.

See Baier , supra note 12, at 255.

Id., at 258.

O'Neill O. , Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press, 2002): at 126.

Id., at 134–36.

For an account of risks of error when non-prescribers enter data manually, see Santell J. P. Kowiatek J. G. Weber R. J. Hicks R. W. , and Sirio C. A. , “Medication Errors Resulting from Computer Entry by Nonprescribers,” American Journal of Health-System Pharmacy 66, no. 9 (2009): 843–853.

Schmidt S. Sheikzadeh S. Beil B. Patten M. , and Stettin J. , “Acceptance of Telemonitoring to Enhance Medication Compliance in Patients with Chronic Heart Failure,” Telemedicine Journal and e-Health 14, no. 5 (2008): 426–433.

See, e.g., Beach M. C. , “Can Patient-Centered Attitudes Reduce Racial and Ethnic Disparities in Care?” Academic Medicine 82, no. 2 (2007): 193–198.

Hoffman S. Podgurski A. , “Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems,” Harvard Journal of Law & Technology 22, no. 1 (2008): 103–165, at 126.

Jones S. Campbell McMenemin J. , and Kibbe D. C. , “The Interoperable Electronic Health Record: Preserving Its Promise by Recognizing and Limiting Physician Liability,” Food & Drug Law Journal 63, no. 1 (2008): 75–87, at 79. These authors also suggest that the formation of the provider patient relationship may take new forms, thus changing the initial premise of malpractice litigation.

Brown S. H. Fischetti L. F. Graham G. Bates J. Lancaster A. E. McDaniel D. Gillon J. Darbe M. , and Kolodner R. M. , “Use of Electronic Health Records in Disaster Response: The Experience of Department of Veterans Affairs after Hurricane Katrina,” American Journal of Public Health 97, Supplement 1 (2007): S136–S141. For an overview of the benefits of EHRs, see Hoffman S. Podgurski A. , “Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems,” Harvard Journal of Law & Technology 22, no. 1 (2008): 103–165.

See, e.g., National Committee on Vital and Health Statistics, “NCVHS Observations on Meaningful Use of Health Information Technology,” at 3, available at <http://www.ncvhs.hhs.gov/090428rpt.pdf> (last visited November 23, 2009).

Office of the National Coordinator for Health Information Technology, “Meaningful Use Matrix,” Draft June 15, 2009, available at <http://healthit.hhs.gov/portal/server.pt/gate-way/PTARGS_0_10741_872719_0_0_18/meaningful%20use%20matrix.pdf (last visited July 29, 2009) [hereinafter Meaningful Use Matrix].

Id.

See, e.g., NCVHS, Transcript of Meeting February 20, 2008, comments of Overhage J. Marc Carr Justine , available at <http://www.ncvhs.hhs.gov/080220tr.htm> (last visited November 23, 2009).

See New York City Department of Health and Mental Hygiene, “The New York City A1C Registry,” available at <http://www.nyc.gov/html/doh/html/diabetes/diabetes-nycar.shtml> last visited July 1, 2009.

See, e.g., Add “Informed Patient Consent” to New York City's Hemoglobin A1C Registry, available at <http://www.petitiononline.com/NYCA1C/petition.html> (last visited July 1, 2009). Additional concerns about the program were that it was initiated in areas of the city with heavily minority populations and that the system for opting-out might have been difficult for patients without ready access to the internet. See generally Krent H. J. Gingo N. Kapp M. Moran R. Neal M. Paulas M. Sarna P. , and Suma S. , “Whose Business is Your Pancreas? Potential Privacy Problems in New York City's Mandatory Diabetes Registry,” Annals of Health Law 17, no. 1 (2008): 1–37; Stoto M. A. , “Public Health Surveillance in the Twenty-First Century: Achieving Population Health Goals While Protecting Individuals' Privacy and Confidentiality,” Georgetown Law Journal 96 (2008): 703–719; Mariner W. K. , “Medicine and Public Health: Crossing Legal Boundaries,” Journal of Health Care Law & Policy 10 (2007): 121–151.

DesRoches C. M. , “Electronic Health Records in Ambulatory Care – A National Survey of Physicians,” New England Journal of Medicine 359 (2008): 50–60.

For example, the particular needs of ophthalmologists are only beginning to be addressed by CCHIT, the Certification Commission for Healthcare Information Technology. American Academy of Opthalmology, “Eye-Care Community Collaborates on HIT Standard Certification Effort,” available at <http://www.aao.org/newsroom/release/20090128a.cfm> (last visited July 29, 2009). Standards for behavioral health providers are also currently under development, Certification Commission for Health Information Technology, Physician's Guide to CCHIT Certification, at 7, available at <http://www.cchit.org/sites/all/files/CCHITPhysiciansGuide08.pdf> (last visited July 29, 2009). No electronic dental record systems currently have CCHIT certification, Dentistry IQ, Gossip about CCHIT, available at <http://community.pennwelldentalgroup.com/forum/topics/gossip-about-cchit?page=1&commentId=2013420%3AComment%3A24297&x=1#2013420Comment24297 (last visited July 29, 2009).

Public Health Service Act, 42 U.S.C. § 290ee-3. The same is true for alcohol treatment, 42 U.S.C. § 290dd-3.

45 CFR § 164.501 (2009).

National Committee on Vital and Health Statistics, Letter to Secretary Leavitt, Re: Individual control of sensitive health information accessible via the Nationwide Health Information Network for purposes of treatment, February 20, 2008, <http://www.ncvhs.hhs.gov/080220lt.pdf> (last visited July 9, 2009).

The segregation is accomplished through the use of SNOMED categories. Testimony of Seth Edlavitch to National Committee on Vital and Health Statistics Subcommittee on Privacy, Confidentiality, and Security, June 9, 2009, available at <http://ncvhs.hhs.gov/090609ag.htm> (last visited July 29, 2009).

National Committee on Vital and Health Statistics, Minutes of the Meeting November 27–28, 2007, available at <http://www.ncvhs.hhs.gov/071127mn.htm> (last visited November 23, 2009).

See generally Terry N. P. Francis L. P. , “Confidentiality and Electronic Medical Records,” Illinois Law Review 2007, no. 2 (2007): 681–735.

See, e.g. Grimm D. A. , “Informed Consent for All! No Exceptions,” New Mexico Law Review 37, no. 1 (2007): 39–83.

Another possibility would be to allow patients to mask information by source – for example, masking records from a particular gynecologist or a psychiatrist. NCVHS considered but rejected this possibility as incompletely protective of sensitive categories of health information. For example, much mental health care is provided by primary care physicians; a strategy of masking by provider source would not protect such sensitive data. See National Committee on Vital and Health Statistics, Re: Individual Control of Sensitive Health Information Accessible via the Nationwide Health Information Network for Purposes of Treatment, available at <http://www.ncvhs.hhs.gov/080220lt.pdf> (last visited November 23, 2009).

See Meaningful Use Matrix, supra note 25.

Transcript, HIT Policy Committee, June 16, 2009, at 30 (remarks of Christine Bechtel), available at <http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11113_873929_0_0_18/HITpolicy_transcript_061609.pdf> (last visited November 23, 2009).

Oldenburg J. , My Health Manager: An Electronic Health Record That Works, presentation at the World Healthcare Congress, April 22, 2008, available at <http://www.slide-share.net/gvanantwerp/kaiser-phr-whcc-2008> (last visited November 23, 2009).

United States Department of Veterans' Affairs, “About MyHealthEVet,” available at <https://www.myhealth.va.gov/mhv-portal-web/anonymous.portal?_nfpb=true&_nfto=false&_pageLabel=aboutMHVHome> (last visited November 23, 2009).

GoogleHealth, available at <https://www.google.com/accounts/ServiceLogin?service=health&nui=1&continue=https%3A%2F%2Fwww.google.com%2Fhealth%2Fp%2F&followup=https%3A%2F%2Fwww.google.com%2Fhealth%2Fp%2F&rm=hide> (last visited July 3, 2009; access restricted).

WebMD, available at <http://www.webmd.com/> (last visited November 23, 2009).

PatientsLikeMe, available at <http://www.patientslikeme.com/> (last visited November 23, 2009).

White Coat Notes, “Beth Israel Deaconess Links to Google Health,” available at <http://www.boston.com/news/health/blog/2008/05/beth_israel_dea_13.html (last visited November 23, 2009). The linkages were designed to allow patients to enter information when they received care outside the Beth Israel Deaconess system, and included as well links to pharmacy data (from CVS) and laboratory data (from Quest Diagnostics).

For example, the chain 24-Hour Fitness offers corporate wellness programs; see All Business website, available at <http://www.allbusiness.com/north-america/united-states-california-metro-areas/984772-1.html> (last visited November 23, 2009). ShapeUptheNation offers a wellness program that provides employers with outcome data such as pounds lost, hours exercised, and steps walked; see Shape Up the Nation website, available at <http://www.shapeupthenation.com/www/employers/investment/> (last visited November 23, 2009). Although these data are reported in to employers in the aggregate, they are collected about individual participants and could easily be entered into the individual medical records.

Hadley J. , “‘Loyalty’ Cards Cause Griping over Swiping: Some Like Savings at Grocers, Others See ‘Big Brother,’” Seattle Post Intelligencer, May 11, 2002, available at <http://www.seat-tlepi.com/local/70072_loyal11.asp> (last visited November 23, 2009). The group is C.A.S.P.I.A.N., Consumers against Supermarket Privacy Invasion and Numbering, and is available at <http://www.nocards.org/> (last visited November 23, 2009).

The National Children's Study, Growing Up Healthy: An Overview of the National Children's Study, at 63, available at <http://www.nationalchildrensstudy.gov/about/stayingin-formed/publications/Pages/ncs_guh_brochure_101906.pdf (last visited November 23, 2009).

Kaiser Family Foundation, National Survey on Consumers' Experiences With Patient Safety and Quality Information, at 7, available at <http://www.cchit.org/sites/all/files/CCHITPhysiciansGuide08.pdf> (last visited November 23, 2009) [hereinafter Kaiser Family Foundation]. The availability of information about physicians outside the provider-patient relationship is discussed further infra note 67 and accompanying text.

Boscarino J. A. Adams R. E. , “Public Perceptions of Quality Care and Provider Profiling in New York: Implications for Improving Quality Care and Public Health,” Journal of Public Health Management Practice 10, no. 3 (2004): 241–250.

National Practitioner Data Bank, Health Care Protection and Integrity Data Bank, available at <http://www.npdb-hipdb.hrsa.gov/> (last visited November 23, 2009).

Commonwealth of Massachusetts, “Welcome to the Massachusetts Board of Registration in Medicine,” available at <http://profiles.massmedboard.org> (last visited November 23, 2009).

HEDIS stands for the Healthcare Effectiveness Data and Information Set, a standardized data set for reports about managed care and preferred provider organizations. HEDIS includes such measures as body mass index or hemoglobin A1C. Patients can get HEDIS report cards on organizations submitting reports to the National Committee for Quality Assurance, available at <http://www.ncqa.org/tabid/60/Default.aspx> (last visited November 23, 2009), as well as rankings published in U.S. News and World Reports, available at <http://www.usnews.com/directories/health-plans/index_html> (last visited November 23, 2009), but these reports do not contain detailed information or information about particular providers.

The draft Meaningful Use Matrix lists such registries for the physician to use for quality improvement as a 2011 objective.

See Meaningful Use Matrix, supra note 25. For a general discussion of clinical decision supports, see Osheroff J. A. Teich J. M. Middleton B. Steen E. B. Wright A. , and Detmer D. E. , “A Roadmap for National Action on Clinical Decision Support,” Journal of the American Medical Informatics Association 14, no. 2 (2007): 141–145.

By contrast, the PatientsLikeMe website features comparisons between the patient's self-reported experience and the self-reported experiences of other patients, in the “share your health profile” function, available at <http://www.patients-likeme.com/> (last visited November 23, 2009).

See, e.g., Kaiser Family Foundation, supra note 51, at 8–9.

See Hall , supra note 2, at 616–617.

See Tang P. Lansky D. , “The Missing Link: Bridging The Patient-Provider Health Information Gap,” Health Affairs 24, no. 5 (2005): 1290–1295.

See, e.g., Mazor K. M. Reed G. W. Yood R. A. Fischer M. A. Baril J. , and Gurwitz J. H. , “Disclosure of Medical Errors: What Factors Influence How Patients Respond?” Journal of General Internal Medicine 21, no. 7 (2006): 704–710.

See the Dartmouth Atlas of Health Care, available at <http://www.dartmouthatlas.org/> (last visited November 23, 2009).

From Atul Gawande's description of care patterns in McAllen, Texas. A. Gawande, “Cost Conundrum: What a Texas Town Can Teach Us about Health Care,” New Yorker, June 1, 2009, available at <http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawandehttp://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande> (last visited November 23, 2009).

Cunningham P. J. , “High Medical Cost Burdens, Patient Trust, and Perceived Quality of Care,” Journal of General Internal Medicine 24, no. 3 (2009): 415–420.

Institute of Medicine, “Conflict of Interest in Medical Research, Education, and Practice,” April 28, 2009, available at <http://www.iom.edu/CMS/3740/47464/65721.aspx> (last visited November 23, 2009).

Institute of Medicine, “Rewarding Provider Performance: Aligning Incentives in Medicare,” Pathways to Quality Health Care Series, September 21, 2006, available at <http://www.nap.edu/catalog.php?record_id=11723> (last visited November 23, 2009).

See, e.g., Tang P. C. Ralston M. Arrigotti M. Fernandez Qureshi L. , and Graham J. , “Comparison of Methodologies for Calculating Quality Measures Based on Administrative Data versus Clinical Data from an Electronic Health Record System: Implications for Performance Measures,” Journal of the American Medical Informatics Association 14, no. 1 (2007): 10–15. One major problem is that claims data capture patients actively receiving care – and thus under-represent patients with given diagnoses who are not receiving the care they should.

Draper D. A. , “Physician Performance Measurement: A Key to Higher Quality and Lower Cost Growth or a Lost Opportunity,” available at <http://www.rwjf.org/files/research/3994.43589.physperformance.no3.pdf> (last visited November 23, 2009).

Darves B. , “Ensuring – and Tracking – Physician Competence,” available at <http://www.nejmjobs.org/career-resources/ensure-physician-competence.aspx> (last visited November 23, 2009).

Safran C. Bloomrosen M. Hammond W. Edward Labkoff S. Markel-Fox S. Tang P. C. , and Detmer D. E. , “Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper,” Journal of the American Medical Informatics Association 14, no. 1 (2007): 1–9 [hereinafter AMIA 2007].

National Committee on Vital and Health Statistics, “Enhanced Protections for Uses of Health Data: A Stewardship Framework for ‘Secondary Uses’ of Electronically Collected and Transmitted Health Data,” December 22, 2007, available at <http://www.ncvhs.hhs.gov/reptrecs.htm> (last visited November 23, 2009).

See AMIA 2007, supra note 71.

Dubler N. Blustein J. Bhalla R. , and Bernard D. , “Informed Participation: An Alternative Ethical Process for Including Patients in Quality-Improvement Projects,” at 69–88 in Jennings B. Baily M. A. Bottrell M. , and Lynn J. , eds., Health Care Quality Improvement: Ethical and Regulatory Issues (New York: Hastings Center, 2007).

Id.

Kaiser Family Foundation, “National Survey on Consumers' Experiences with Patient Safety and Quality Information – Summary and Chartpack,” at 12, available at <http://www.kff.org/kaiserpolls/7209.cfm> (last visited November 23, 2009).

Institute of Medicine, “Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research,” February 4, 2009, available at <http://www.iom.edu/CMS/3740/43729/61796.aspx> (last visited November 23, 2009). [hereinafter IOM, Beyond].

Id., at 8, 83.

Id., at 34–35.

Participation in research may, however, be linked to the production of public goods and thus arguably to patients' obligations to participate. See Schaefer G. O. Emanuel E. J. , and Wertheimer A. , “The Obligation to Participate in Biomedical Research,” JAMA 302, no. 1 (2009): 67–72.

Nair K. Willison D. J. Holbrook A. M. , and Keshavjee K. , “Patients' Consent Preferences Regarding the Use of Their Health Information for Research Purposes: A Qualitative Study,” Journal of Health Services Research Policy 9, no. 1 (2004): 22–27; Willison D. J. Keshavjee K. Nair K. Gold-Smith C. , and Holbrook A. M. , “Patients' Consent Preferences for Research Uses of Information in Electronic Medical Records: Interview and Survey Data,” British Medical Journal 326, no. 7385 (2003): 373.

Rothstein M. , “Improve Privacy by Eliminating Informed Consent? IOM Report Misses the Mark,” Journal of Law, Medicine & Ethics 37, no. 3 (2009): 507–509.

See AMIA 2007, supra note 71.

Francis L. Battin M. P. Jacobson J. A. , and Smith C. , “Syndromic Surveillance and Patients as Victims and Vectors,” Journal of Bioethical Inquiry 6, no. 2 (2009): 187–195.

Lee L. M. Gostin L. O. , “Ethical Collection, Storage, and Use of Public Health Data,” JAMA 302, no. 1 (2009): 82–84.

See AMIA 2007, supra note 71.

United States Department of Health and Human Services, “What Effect Do the ‘Marketing’ Provisions of the HIPAA Privacy Rule Have on Federal or State Fraud and Abuse Statutes?” available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/use/291.html> (last visited November 23, 2009). Department of Health and Human Services, “Standards for Privacy of Individually Identifiable Health Information,” Federal Register 65 (December 28, 2000): 82461–82830.

45 C.F.R. § 164.514 (2009).

National Committee on Vital and Health Statistics, “Hearing on Personal Health Records, Testimony of Jamie Heywood,” May 20, 2009, available at <http://ncvhs.hhs.gov/090520tr.htm> (last visited November 23, 2009).

See International Society for Telemedicine and Ehealth, available at <http://www.isft.net/cms/index.php?id=1> (last visited November 23, 2009).