Patients’ Rights to Privacy & Anonymity

Read the original entry in AMA Manual of Style, 10^th Edition, pages 229–232.

Privacy is a state or condition of limited access to matters of a personal nature, including but not limited to personal information, as well as an individual’s right to control such access. When individuals grant others some form of access to themselves (e.g., during a patient-clinician encounter), the individuals are exercising their right to privacy, but they are not waiving this right. Thus, a loss of privacy depends on the kinds or amount of access, who has access, through what means, and to which aspect of a person. Historically, medical journals have taken steps to protect patients’ rights to privacy and anonymity, including the deletion of patients’ names, initials, and assigned numbers from case reports; removal of identifying information from radiographs, digital images, and laboratory slides; and the deletion of identifying details from descriptions of patients or study participants in published articles. Until the late 1980s, placing black bars over the eyes of patients in photographs was accepted as a way to protect the identities of patients. However, journals began to discontinue this practice when it became apparent that bars across eyes do not protect identities. Photographs with bars place over the eyes of patients should not be used in publication.

Case descriptions and case reports serve as important contributions to the medical literature and make up a substantial portion of some journal content, especially in some specialties. Traditionally, such reports have included specific details about patients. However, as Pikin and Scott note, “The degree of detail and specificity is sometimes sufficient to permit identification, and at the same time, it is often much greater than necessary for any message the author means to convey.” Only those details essential for understanding and interpreting a specific case report of case series should be provided. In most instances, the description can be more general than specific to ensure anonymity, without loss of meaning. For example, Pitkin and Scott suggest that “a 34-year-old para 2-0-0-2 black woman at 23 weeks’ gestation” can be described as “a multiparous woman in midgestation.” Although the degree of specific needed will depend on the context of what is being reported, specific ages, race/ethnicity, and other sociodemographic details should be presented only if clinically or scientifically relevant and important. 

Patients have occasionally recognized descriptions of themselves in medical articles without accompanying photographs and even after “superfluous social details” have been removed. To protect a patient’s right to privacy, nonessential identifying data (e.g., sex, age, occupation) generally should be removed from a manuscript, unless clinically or epidemiologically important. However, omitting certain details may be problematic. For example, omitting a patient’s occupation from a case report might seem reasonable at first, but this information may be needed later during an occupational exposure assessment or an epidemiologic investigation. More important, authors and editors should not alter or falsify details in case descriptions to secure anonymity because doing so may introduce false or inaccurate data into the medical literature. For example, changing the city in which the patient lived may seem innocuous, until another investigator subsequently cites the case report and the erroneous city in an epidemiologic analysis of locations of disease outbreaks. 

Several cases have occurred in which patients who had not consented to publication of their personal details in medical journals were recognized by themselves or others in specific articles or subsequent news coverage. The ICMJE and a number of medical journals have strengthened their rules for protecting patients’ rights to privacy by adding a specific requirement for informed consent from any potentially identifiable patient. 

Therefore, when detailed case descriptions or photographs of faces or identifiable body parts are included in a manuscript that might permit any patient to be identified, authors should obtain written permission from the identifiable patients (or legally authorized representatives) to publish the information and should send a copy of the permission to the journal. The same applies to video files submitted for publication. Such consent should include an opportunity for the patient to read the manuscript to be submitted for publication or waive the right to do so. Nonspecific institutional consent forms that do not include a provision for a patient to review the information to be published or waive that right are not acceptable. An example of the patient permission form used by JAMA and the Archives Journals appears in the box. 

For manuscripts accepted for publication, when informed consent from identifiable patient(s) has been obtained, journals should indicate that such consent was obtained, either in the “methods” section, if appropriate, or in the “acknowledgment” section at the end of the article.

• Methods: This investigation was approved by the medical center’s institutional review board. The 12 patients in this case series provided written consent for the investigation. In addition, each patient was given an opportunity to review the manuscript and consented to its publication.
• Acknowledgement: We are grateful to the 2 patients who graciously provided permission after reviewing the manuscript to publish this information for the medical community. 

Some editors and authors have commented that obtaining consent from identifiable patients is too burdensome. Asking those who so argue to consider that the identifiable person could be themselves or a close relative might help convey the rationale for this requirement. Others have argued that the process of obtaining such consent may be disturbing to the patient or the patient’s family members. However, subsequent discovery of unauthorized publication of a patient’s information that results in identification or unwanted publicity would be even more disturbing and may also violate national privacy laws such as the US Health Insurance Portability and Accountability Act (HIPAA). Moreover, the publication of unauthorized identifiable patient information could result in legal claims related to invasion of privacy, allegations of professional conduct, or criminal penalties. 

At JAMA, whether a manuscript contains identifiable patient information is determined on a case-by-case basis. In most cases, potentially identifiable data are removed from the manuscript. However, if such details are required, the editors will assess the risk of identifiability after considering the type and amount of detail that is applicable, relevant identifiable information contained in previously published reports involving the same patient(s) or news reports that have resulted in publicity. (Note: Previous publication or news coverage does not eliminate a patient’s right to privacy and does not negate the need for patient permission.) If the editors determine that the information could result in recognition—even if only by the patient—they will ask the author to delete identifiable details and material. This can be done with most manuscripts. However, if “deidentification” is not possible, the editors will ask the author to obtain consent from the patient, which includes offering the patient the opportunity to read the submitted manuscript. In this case, if the patient cannot be located or refuses to consent to publication, the manuscript will not be published. 

Rights in Published Reports of Genetic Studies. The rule for ethical approval of studies and for obtaining informed consent also apply to genetic studies of family pedigrees and population-based samples. However, obtaining written informed consent from all members of a large pedigree (many of whom may be deceased or unaware of the collection of family data) may be difficult or impossible. Proposals for obtaining some form of group consent and for avoiding the publication of information about identifiable family members who will not give their permission have been considered. All such studies must be reviewed by an independent ethics review committee or IRB, and if the individual members of the family or population-based sample are considered to be “human subjects” and identifiable, informed consent may be required; otherwise, a waiver may be granted. The “methods” section of all reports of genetic studies should be include statements about the ethics committee/IRB review and approval or waiver and information about informed consent procedures or waivers.

As with reports of other types of studies, nonessential identifying information should be removed from reports of genetic studies. However, data should not be altered in an attempt to protect the identities of individuals and family members, although relevant information may be masked. For example, in pedigree charts, triangles can be used instead of squares and circles if the sex of family members is not essential to the report (e.g., if the disease is known not to be sex-linked), or sections of pedigrees may be excluded from pedigree charts or not described in detail if appropriate consent could not be contained as long as omissions are noted. 

Patients’ Rights in Essays and News Reports in Biomedical Journals. In essays and news stories in biomedical journals, descriptions and photographs of individuals are often included. However, if these descriptions or photographs depict patients or anyone in an actual patient-clinician encounter who is identifiable, the authors or writers should be asked to “deidentify” those patients. Identifying details may be omitted but may not be altered or falsified. If patients cannot be deidentified, their written informed consent must be obtained. Fictionalized cases and reports generally should not be presented except in rare cases and unless this is made clear to readers (e.g., a hypothetical case to explain a clinical scenario or a fictional essay in which it is made clear to readers that it is fictional.)  In news stories, third-party photographs should not be used if they include identifiable patients, unless consent for publication has been obtained. Appropriately credited stock or staged photographs depicting patients or stimulating a patient-clinician encounter are acceptable.