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Posted by on Jun 22, 2014 in Bioethics, Patient privacy | 0 comments

Who owns a patient’s excised tissue? (22.06.2014)

Who owns a patient’s excised tissue? (22.06.2014)

There’s been an interesting – and somewhat disturbing – development in Canada, for both bioethics and (patient) privacy, due to a recent court case. Although the case was heard in Ontario, not in Canada’s Supreme (i.e. federal) Court, it will likely have an impact throughout Canada. (One exception is the Province of Québec, as its legal system is based on a Civil Code rather than on precedent-based Common Law (1). This means that previous court decisions and opinions aren’t used by judges and courts to make future decisions.

Living in the Montréal area, as I do, sometimes provides an interesting – almost from overseas – view of court decisions in other Canadian provinces.) Timothy Caulfield (2) – Research Director of the Health Law Institute at the University of Alberta – fairly succinctly summed up the decision in a newspaper opinion piece earlier this week: “The conclusion? Yep, human tissue is a form of personal property. Not only that, once it is removed from a patient, it is owned by the hospital” (3).

He goes on to argue that using the terminology of property law isn’t appropriate for human tissue. Although I agree that applying the legal concept of property to human tissue is problematic, I believe this case raises larger issues of bioethics and patient privacy protection. My view is that human tissue should be viewed – at least – under the lens of patient privacy protection. Let’s start with a fairly simple question: What’s reasonable in terms of privacy, in the context of medical care in Canada?

Last year this topic was broached in a bioethics case study for The Royal College of Physicians and Surgeons of Canada (The Royal College), although from the perspective of a patient who may present a risk of harm to others. That article stated that “Violating an autonomous patient’s confidentiality infringes that patient’s right to control access to their personal information… Keeping a patient’s privacy and confidentiality is a reasonable expectation in the physician-patient relationship” (4). I doubt that any of us would disagree.

For the particular Ontario court case we’re considering, the question could best be presented as whether tissue should – in some manner – be considered to be a patient’s personal information and thus subject to the ‘reasonable expectation’ above. The Royal College seems to also have addressed that topic, in a bioethics primer on Canadian privacy laws.

In referring specifically to the Personal Health Information Protection Act (PHIPA) of Ontario, the authors state that personal health information (PHI) “is defined under PHIPA to include identifying information about an individual, in oral or recorded form, relating to: their physical or mental health (including family history); the provision of health care (including the name[s] of provider[s]); plans of service for long-term care; payments or eligibility for health care; information relating to specimens, tissues or organ donation, and test or exam results; health numbers; and the identity of any substitute decision-maker” (5).

Photo of a woman's arms with several bandages from intravenous lines

Photo: Sandra Woods

Note the phrase ‘information relating to specimens, tissues…’ in the above statement. It’s important to note here that non-identifiable patient information is excluded from PHIPA protection; the underlying concept is that information that isn’t identifiable doesn’t require protection under the law. If the information can’t be linked to a particular patient, for example due to a secure anonymization or de-identification process – or it was never identified in the first place (e.g. an anonymous checkmark-only health survey, with no identifiable handwriting) – then its release or distribution wouldn’t constitute any type of potential harm or risk to the particular patient.

The Royal College bioethics primer also states that: “Information is identifying under PHIPA where it either identifies the individual or it is reasonably foreseeable that it could be used to identify the individual, either alone or in combination with other information” (5). Note that last phrase.

My view – from a bioethics and patient privacy protection perspective, rather than from a medical perspective – is that we should consider it to be ‘reasonably foreseeable’ that human tissue could be used to identify an individual patient. With the advent of genetic testing and on-going research into that field, I believe the Ontario court should have considered “the vanishing concept of data de-identification as it relates to genomic data” (6).

If PHIPA protects patient information which is either identifiable in its own right or is identifiable “in combination with other information”, then my view is that human tissue removed in hospital should be viewed as something we could reasonably foresee would identify an individual patient.

The position of Timothy Caulfield is that the concept of property law is inappropriate for consideration of human tissue, removed from a patient’s body in a hospital setting. I agree, and suggest that human tissue in this situation should instead have been viewed as a question of patient privacy protection.

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(1) Government of Canada, Department of Justice: “Where our legal system comes from”; 2014

http://www.justice.gc.ca/eng/csj-sjc/just/03.html

(2) Timothy Caulfield – of the University of Alberta – is the Canada Research Chair in Health Law and Policy, a Professor in the Faculty of Law and School of Public Health, as well as the Research Director of the Health Law Institute (HLI); all at the University of Alberta. His biographical information is available on the website of the HLI at:

http://www.hli.ualberta.ca/People/TimothyCaulfield.aspx

(3) Timothy Caulfield: “Who owns your tissue? You’d be surprised”; The Globe and Mail, Opinion letter; 20 Jun 2014;

https://sec-theglobeandmail-com.cdn.ampproject.org/c/s/sec.theglobeandmail.com/opinion/who-owns-your-tissue-youd-be-surprised/article19256582/?service=amp

(4) Andrew McRae, MD, PhD, FRCPC; 3.3.3 Reporting Patients – Harm to Others (Public Safety); The Royal College of Physicians and Surgeons of Canada; Bioethics Cases, Section III Professionalism, 3.3 Duty of Confidentiality; 23 Dec 2013 (update);

http://www.royalcollege.ca/rcsite/bioethics/cases/section-3/reporting-patients-harm-others-public-safety-e

(5) Paul B. Miller, JD, PhD, Sujit Choudhry, LLB, LLM, Angela Campbell, BCL, LLB, LLM: Legal Regulation of the Physician-Patient Relationship; The Royal College of Physicians and Surgeons of Canada; Bioethics Primers; undated;

http://www.royalcollege.ca/rcsite/bioethics/primers/legal-regulation-physician-patient-relationship-e#privacy

(6) Kimberly Shoenbill, Norman Fost, Umberto Tachinardi, Eneida A Mendonca: “Genetic data and electronic health records: a discussion of ethical, logistical and technological considerations”; J Am Med Inform Assoc; 21(1): 171–180; Jan 2014:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3912723/

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