compose a paper

Transparent Electronic Health Records and Lagging Laws Bryan S. Lee, MD, JD; Jan Walker, RN, MBA; Tom Delbanco, MD; and Joann G. Elmore, MD, MPH

Millions of patients are accessing their medical re-cords online via secure electronic patient portals. They are also increasingly uploading data directly into their records, and many clinicians now offer patients ready and ongoing access to the notes that document encounters. In response, patients report improved un- derstanding of their care, better recall, enhanced ad- herence to care plans, and an increased sense of con- trol over their health (1).

Although these changes hold promise for improv- ing the value and safety of health care, some opportu- nities are hindered by legal constraints dating back to when patients rarely saw their physical charts. To reflect new technical and cultural realities, this legal frame- work will require ongoing consideration and revision, ideally reflecting strong clinician and patient input and leadership. To highlight potential legal issues and sug- gest strategies for active clinician involvement, we de- scribe areas that often engender discussion and debate.

DISAGREEMENT OVER CONTENT As patients increasingly read their medical records,

they will disagree with content, find errors, and request changes. Online access makes poor-quality documen- tation more apparent, particularly when notes are cop- ied forward, templates predominate, and the patient's story is obscured or disappears. The Health Insurance Portability and Accountability Act (HIPAA) guarantees patients the right to access and control distribution of their protected health information (2). Although it per- mits patients to request amendments, HIPAA reserves most decision-making authority for providers, and the general legal principle is that the provider owns the record. However, “ownership” will become less clear as records increasingly include information uploaded or contributed by patients, from device data to correc- tions or new text. The legal status of patient-derived content will need clarification, and clinicians, patients, and lawyers will need to join in crafting smoother pro- cesses to resolve disputes and revise documentation.

A LITIGIOUS SOCIETY Conceivably, clinicians sued for malpractice may

claim that plaintiffs who can review and at times con- tribute to their online records bear increased responsi- bility for their outcomes, including bad ones. However, merely accessing records does not prove that the pa- tient has reviewed them, and juries are unlikely to ex- pect patients to understand a note, test finding, or ra- diographic report. Conversely, malpractice plaintiffs are often motivated by fear of a cover-up, feeling mis- informed, or a desire to determine whether an error occurred. Transparent access may build trust, allay fears, and help identify important errors before adverse consequences ensue, reducing clinicians' malpractice liability overall (3–5).

ACCESS TO MINORS' MEDICAL RECORDS With few exceptions, HIPAA grants parents control

of minors' medical records as their representatives and allows them to prevent their children from accessing online notes. However, providers can exclude parents if they have a reasonable belief that a child is being abused or think that parental access is not in the child's best interest. Parents can also lose control if the minor has a right to seek independent treatment (for exam- ple, a condition-based exception, such as pregnancy, or care sought by an emancipated minor). Further- more, 14 states have “mature minor exceptions,” allow- ing minors in some circumstances to consent to medi- cal care without parental involvement, and 3 others allow minors to consent regardless of age or maturity (6). In these situations, consenting minors can control their health information without parental permission (7). Adding to this complexity, a 2002 federal rule al- lows state laws that afford greater parental control to overrule federal laws when conflicts exist.

Because of the burden of case-by-case consider- ation and potential liability arising from disagreements, many providers simply deny electronic access to mi- nors and their parents. This is unfortunate, particularly for adolescents for whom online access could be a nat- ural way to learn about their health and how to interact with the health care system. Providers can promote these benefits by encouraging vendors of electronic health records (EHRs) to develop capabilities for differ- ential access, such as allowing adolescents but not par- ents to view information about sexual health (8). Clini- cians and patients could also work to convince legislators or the U.S. Department of Health and Hu- man Services to undo the regulation allowing state law to preempt federal law.

MENTAL ILLNESS AND CLINICIANS' NOTES HIPAA prevents persons from viewing their psycho-

therapy notes if they reside in a segregated part of pa- per or EHRs. It otherwise allows access to mental health notes, with some state laws overriding HIPAA and offer- ing broader access that includes psychotherapy notes. Mental health professionals are now exploring the ef- fects of open and, at times, cogenerated online notes as part of the therapeutic process (9). Overall, clinicians and patients need to advocate for a more uniform land- scape, such as a general principle of open access un- less the clinician believes it would harm an individual patient.

SUSPECTED ABUSE AND THE EHR All states require clinicians to report known or sus-

pected child abuse, most require reporting elder abuse, and some require reporting spousal abuse. Fearing inadvertent viewing by the abuser, abuse vic-

This article was published at www.annals.org on 24 May 2016.

Annals of Internal Medicine IDEAS AND OPINIONS

© 2016 American College of Physicians 219

tims may feel endangered by online access to records and could decide not to confide in their clinician. Al- though clinicians can choose to hide or not document suspected abuse online, most current EHRs make this inconvenient. To protect patients, clinicians and pa- tients could advocate for laws prohibiting documenta- tion of abuse from appearing in online portals.

SHARING NOTES AND PRIVACY Many patients, family members, and other caregiv-

ers report benefits from sharing clinicians' notes. Much sharing is informal, with patients reviewing their re- cords with family members or providing passwords to persons they trust. Unfortunately, patients face substan- tial privacy risks from sharing passwords, and clinicians and patients should advocate for separate, patient- authorized “proxy access” for caregivers.

Patients could post clinicians' notes on social me- dia and potentially threaten their reputation, particu- larly if notes are altered or the commentary is libelous. Currently, it is difficult for clinicians to have such mate- rial removed, and the Communications Decency Act prevents them from holding a Web host accountable (10). Clinicians would benefit greatly from legal mech- anisms that protect them from online defamation.

CLINICIAN LEADERSHIP AND NEXT STEPS Patients' electronic access to clinicians' notes will

fundamentally change the medical record as providers

modify how they write notes and patients amend, an- notate, and add information. Overall, we anticipate that these changes will benefit patients and providers and deepen the clinician–patient relationship. However, current legal regulations will become increasingly problematic as medical records evolve into new for- mats and roles. Clinicians should join consumers, poli- cymakers, regulators, informatics experts, ethicists, leg- islators, and lawyers to help establish a legal landscape that supports this evolution (Table).

From the University of Washington School of Medicine, Seat- tle, Washington; Altos Eye Physicians, Los Altos, California; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Acknowledgment: James Ralston, MD, MPH, and Benjamin W. Moulton, JD, MPH, reviewed an early version of the man- uscript.

Grant Support: By the Robert Wood Johnson Foundation, Na- tional Cancer Institute K05 CA 104699, and a department of ophthalmology grant from Research to Prevent Blindness.

Disclosures: Disclosures can be viewed at www.acponline.org/ authors/icmje/ConflictOfInterestForms.do?msNum=M15-2827.

Requests for Single Reprints: Bryan S. Lee, MD, JD, Altos Eye Physicians, 762 Altos Oaks Drive #1, Los Altos, CA 94024; e-mail, [email protected].

Current author addresses and author contributions are avail- able at www.annals.org.

Ann Intern Med. 2016;165:219-220. doi:10.7326/M15-2827

References 1. Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, et al. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012;157:461-70. [PMID: 23027317] doi:10.7326/0003-4819-157-7-201210020-00002 2. HIPAA, Pub. L. No. 104-191 (1996); Privacy Rule, 45 C.F.R. § 160, 45 C.F.R. § 164 (2002). 3. Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following peri- natal injuries. JAMA. 1992;267:1359-63. [PMID: 1740858] 4. Huycke LI, Huycke MM. Characteristics of potential plaintiffs in malpractice litigation. Ann Intern Med. 1994;120:792-8. [PMID: 8147552] 5. Bell SK, Folcarelli PH, Anselmo MK, Crotty BH, Flier LA, Walker J. Connecting patients and clinicians: the anticipated effects of open notes on patient safety and quality of care. Jt Comm J Qual Patient Saf. 2015;41:378-84. [PMID: 26215527] 6. Coleman DL, Rosoff PM. The legal authority of mature minors to consent to general medical treatment. Pediatrics. 2013;131:786-93. [PMID: 23530175] doi:10.1542/peds.2012-2470 7. Hickey K. Minors' rights in medical decision making. JONAS Healthc Law Ethics Regul. 2007;9:100-4. [PMID: 17728582] 8. Bourgeois FC, Taylor PL, Emans SJ, Nigrin DJ, Mandl KD. Whose personal control? Creating private, personally controlled health re- cords for pediatric and adolescent patients. J Am Med Inform Assoc. 2008;15:737-43. [PMID: 18755989] doi:10.1197/jamia.M2865 9. Kahn MW, Bell SK, Walker J, Delbanco T. A piece of my mind. Let's show patients their mental health records. JAMA. 2014;311: 1291-2. [PMID: 24691603] doi:10.1001/jama.2014.1824 10. 47 U.S.C. § 230(c)(1) (2015).

Table. Problem Areas and Approaches to Resolution

General Give patients access to their full records by default Conduct studies addressing the effects of fully transparent medical

records (e.g., track changes in malpractice claims, capture patient- identified medical errors, study behaviors in adolescents with access to records, examine the effect on patients with mental illness)

Disagreement over medical record content Clarify the legal status of patient-derived content Establish mechanisms that permit transparent and parallel docu-

mentation of patient and clinician disagreement and commentary Develop simpler universal processes than current HIPAA

requirements to resolve disputes and revise documentation Minors’ access to medical records

Promote separate electronic health records for teens that address conditions justifying parental exclusion

Encourage electronic record vendors to separate and at times shield parts of the record involving reproductive health, thereby facilitating appropriate shared access for teens and their parents

Work toward making electronic health records available to teens as the default, and adopt uniform federal policies that replace state-by-state variation

Mental illness and clinicians’ notes Explore legal mechanisms that offer open access to all clinicians'

notes, including those written by mental health professionals, unless the clinician believes access would harm an individual patient

Suspected abuse of patients Encourage consistency among states in documentation of practices

that address abuse or suspected abuse Consider federal legislation prohibiting the placement of docu-

mentation of abuse or suspected abuse on online patient portals Shared notes and privacy

Develop universal “proxy access” mechanisms for family members and caregivers

Develop legal mechanisms to protect clinicians from online defamation

IDEAS AND OPINIONS Transparent Electronic Health Records

220 Annals of Internal Medicine • Vol. 165 No. 3 • 2 August 2016 www.annals.org

Current Author Addresses: Dr. Lee: Altos Eye Physicians, 762 Altos Oaks Drive #1, Los Altos, CA 94024. Ms. Walker and Dr. Delbanco: Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Bos- ton, MA 02215. Dr. Elmore: Department of Internal Medicine, University of Washington, Harborview Medical Center, Box 359780, 325 Ninth Avenue, Seattle, WA 98104.

Author Contributions: Conception and design: B.S. Lee, J. Walker, T. Delbanco, J.G. Elmore. Analysis and interpretation of the data: B.S. Lee, J. Walker, T. Delbanco. Drafting of the article: B.S. Lee, T. Delbanco. Critical revision of the article for important intellectual con- tent: B.S. Lee, J. Walker, T. Delbanco, J.G. Elmore. Final approval of the article: B.S. Lee, J. Walker, T. Delbanco, J.G. Elmore. Obtaining of funding: J. Walker, T. Delbanco. Administrative, technical, or logistic support: T. Delbanco. Collection and assembly of data: B.S. Lee, T. Delbanco.

Annals of Internal Medicine

www.annals.org Annals of Internal Medicine • Vol. 165 No. 3 • 2 August 2016

Copyright © American College of Physicians 2016.