GDPR: Patient consent and the law
Suzanne Lurie
Practice Management, 8 May 2019; 29 (5) Legal
Abstract
This article examines the lawful bases for processing data under GDPR (general data protection regulation), why consent is not an appropriate lawful basis and which lawful basis a clinician should rely on for the processing of personal data.
Category: Rights/Legal/Legislative
Declaration of the Rights of People Affected by Tuberculosis
Declaration of the Rights of People Affected by Tuberculosis
STOP TB Partnership, TB People
Article 12. Right to informed consent, May 2019; pp 15-16
Excerpt
Every person affected by tuberculosis has the right to informed consent.
This means respecting a person’s autonomy, self determination and dignity through voluntary health services delivery. It includes the right to informed consent—verbal or written, depending on the situation—to all forms of testing, treatment and medical research associated with tuberculosis, with information provided in an age and gender appropriate, culturally sensitive manner, imparted in a non-technical, comprehensible manner in a language understood by the person receiving the information. For children affected by tuberculosis who lack capacity to give informed consent, all decisions made by their parents or legal guardians with respect to testing, treatment or medical research associated with tuberculosis must be made in the best interests of the child, based on accurate medical evidence.
The right to informed consent includes the right to refuse health care for tuberculosis, in accordance with Chapter 15 of the World Health Organization’s Ethics Guidance for the Implementation of the End TB Strategy. The Ethics Guidance establishes that it is never appropriate to force treatment of people with tuberculosis because, among other things, it amounts to an invasion of bodily integrity and may put health care workers at risk…
Editor’s note: Full text of the declaration is available at the title link above.
Medicolegal Importance of Consent in Medical Practice: A Study in Tertiary Medical Centre of Barabanki U.P.
Medicolegal Importance of Consent in Medical Practice: A Study in Tertiary Medical Centre of Barabanki U.P.
Singh Amit Kumar, Singh Anju, Singh DK
Indian Journal of Forensic Medicine & Toxicology, 7 May 2019; 13(2) pp 26-29
Abstract
Introduction
The Term consent means voluntary agreement, compliance or permission. section 13 of the Indian Contract Act lays down that two or more persons are said to consent when they agree upon the same thing in the same sense(meeting of the minds). From the times immemorial, medical practitioners played paternalistic role and were trusted with the responsibility of deciding the best treatment for their patients. With time, doctor patient relationship has changed from paternalistic to service provider and consumer type relationship. Patient being the consumer of services provided by the medical practitioner, have the right to full information concerning their diagnosis, treatment options, prognosis and possible complication. Informed Consent is the back of Patient’s Autonomy. The advancement in medical technology has further increased its importance. In the developing countries including India, general physicians play a vital role in providing health care to the patients but unfortunately majority of them are unaware about the ethical aspects of Medical Practice.
Method
Objective: To determine the level of awareness about consent among faculty members in Tertiary Medical centre of Barabanki U.P.
Period of study
2Month.
Material and method
A questionaire exploring the awareness about consent was offered to the faculty member of MIMS, Barabanki U.P.
Results
The survey revealed that 12 questionaire were given to RMP of MIMS, out of 12 questions in 7 questions more than 50% of RMP were aware of correct response and in 5 questions more than 50% of RMP were unaware of requirement/procedure obtaining consent in various clinical situations.
Conclusions
They were aware of only those situations which are discussed and debated at various forums.
US State Regulation of Decisions for Pregnant Women Without Decisional Capacity
US State Regulation of Decisions for Pregnant Women Without Decisional Capacity
Research Letter
Erin S. DeMartino, Beau P. Sperry, Cavan K. Doyle, Julie Chor, Daniel B. Kramer, David M. Dudzinski, Paul S. Mueller
JAMA, 23 April 2019; 321(16) pp. 1629-1631
All US states have laws addressing decision making for individuals who cannot make their own medical decisions, including provisions for advance directives and processes authorizing relatives or interested persons to direct care as surrogate decision makers,1 although variation among state laws is increasingly recognized.2,3 However, the prevalence and content of state statutes and official advance directive documents addressing “treatment decisions for divisionally incapacitated pregnant women” is unknown.
Legal review of the civil, criminal, and administrative consequences of informed consent violation in medical practice
Legal review of the civil, criminal, and administrative consequences of informed consent violation in medical practice
Vallejo-Jiménez, Geovana A.a; Nanclares-Márquez, Julianab
Colombian Journal of Anesthesiology, April-June 2019; 47(2) pp 107–112
Abstract
Introduction
The informed consent (IC) ensures respect of the patient’s rights to information, freedom, and autonomy. However, when the physician neglects the obligation to inform, legal consequences may follow, including the award of damages or even imprisonment.
Objective
To analyze the legal implications for a medical practitioner who fails to obtain the patient’s IC.
Methodology
Based on the relevant jurisprudence and legal decisions. With regards to the former, the decisions and legal precedents of the Colombian High Courts with regards to IC and medical practice were studied, emphasizing the rulings of the State Council and the Supreme Court of Justice (civil and penal chambers). With regards to the legal decisions, the analysis enabled the review, systematization and interpretation of the discussions generated around the topic of interest, pursuant to the doctrine or research on civil administrative, and criminal law.
Results
There is consensus in the Colombian jurisprudence about the liability of the healthcare professional and of the state when the IC or any of its component parts is missing in the doctor–patient relationship. Nevertheless, there are different standpoints, particularly in the criminal arena, where a lack of unanimity exists with regards to this issue.
Conclusion
Any violation of the IC or the lack of an IC, could give rise to the practitioner’s civil liability and disciplinary actions, in addition to the administrative liability of the State, but there should be no criminal liability for the physician.
The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework
The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework
Giuseppe R. Gristina, Lucia Busatta, Mariassunta Piccinni
Minerva Anestesiologica, 2019 April; 85(4) pp 401-11
Abstract
The Italian Parliament has recently approved a law on informed consent, advance directives and advance care planning. The law also deals with health care proxy and health care decisions for minors and adults who are not able to give consent. The Italian law arrived quite late in comparison with other European countries. After several years of debate on the need to approve such a law, the focus has now shifted to the assessment of the legislative provisions and their impact on clinical practice. In this article, the authors firstly offer an overview of the findings from the empirical research regarding the use of the different legal tools in the field of intensive care medicine; secondly, they present the tools now provided by law no. 219/2017 particularly with regard to the decision-making processes in the Intensive Care Unit (ICU); thirdly, the authors offer a comparison between the new Italian law and other European legal orders, with special reference to France, Spain, Germany and England. The aim of the article is to assess the degree of innovation of the law vis-à-vis the previous framework
Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation
Informed Consent and Advance Care Directives: Cornerstones and Outstanding Issues in the Newly Enacted Italian Legislation
Gianluca Montanari Vergallo, Antonio G. Spagnolo
The Linacre Quarterly, 29 March 2019
Abstract
This article’s authors delve into, and comment on, some of the key provisions within law no. 219, passed in 2017, which came into full effect in 2018. The legislation presents several innovative aspects: (a) communication time is equated to care; (b) patients may turn down lifesaving treatments, yet doctors must put in place all suitable support processes, from a psychological standpoint as well, in order to make sure that patients make informed decisions in full awareness; (c) refusal to treatment may be expressed prior to the onset of the disease making the patient incapable, as long as the advance directive is laid out by a mentally capable adult who has been provided with all relevant medical information available as to the consequence of a refusal to undergo a given treatment; (d) artificial nutrition and hydration are tantamount to treatment; thus, they may not be carried out and kept in place in absence of valid consent; (e) patients may appoint a healthcare proxy holder, tasked with interacting with doctors and caregivers and expressing consent or refusal; (f) patient will, whether current or advance, must be complied with even under emergency or urgency conditions, provided that clinical conditions and circumstances make it possible to acquire it; (g) doctors may disregard advance directives only when specifically provided for by the law; (h) patients may not demand treatment deemed to be illegal or running counter to ethical codes or scientific evidence. The new legislation, therefore, is meant to uphold the right to exercise self-determination as well as the patient’s quality of life, yet ensuring that doctors remain fully capable of making the decisions that they are best positioned to.
How Democracy Can Inform Consent: Cases of the Internet and Bioethics
How Democracy Can Inform Consent: Cases of the Internet and Bioethics
Carol C. Gould
Journal of Applied Philosophy, 22 March 2019; Special Issue
Abstract
Traditional conceptions of informed consent seem difficult or even impossible to apply to new technologies like biobanks, big data, or GMOs, where vast numbers of people are potentially affected, and where consequences and risks are indeterminate or even unforeseeable. Likewise, the principle has come under strain with the appropriation and monetisation of personal information on digital platforms. Over time, it has largely been reduced to bare assent to formalistic legal agreements. To address the current ineffectiveness of the norm of informed consent, I suggest that we need a notion of structural injustice (on a distinctive interpretation, elaborated here, which takes account of unequal power and property relations). I then argue that in order to protect and enhance people’s freedom, we have to go beyond traditional applied ethics and introduce perspectives from democratic theory and social philosophy. I attempt to show how applications of the ‘all‐affected principle’, together with new forms of democratic participation, deliberation, and representation can helpfully frame the narrower principle of informed consent. There is an important role for what we could call collective consent, and informed consent can only succeed in increasing individual agency if it is situated within enhanced forms of democratic decision‐making.
Democracy as Uninformed Non‐Consent
Democracy as Uninformed Non‐Consent
Jason Brennan
Journal of Applied Philosophy, 14 March 2019; Special Issue
Abstract
Carol Gould argues that democratic institutions can serve as mechanisms of informed consent or could at least facilitate creating regulations and other structures which facilitate informed consent in bioethics, medicine, and elsewhere. I am sceptical. I argue that democracies cannot serve as vehicles of consent, let alone informed consent. Further, the problems of democratic ignorance and irrationality created significant barriers to democratic deliberation helping to produce better regulations or conditions for informed consent. Democracy is not a good surrogate for consent.
Ethical failings of CPSO policy and the health care consent act: case review
Ethical failings of CPSO policy and the health care consent act: case review
Joshua T. Landry, Rakesh Patel, David Neilipovitz, Kwadwo Kyeremanteng, Gianni D’Egidio
BioMed Central Medical Ethics, 19 March 2019; 20(20)
Abstract
End-of-life disputes in Ontario are currently overwhelmingly assessed through the singular lens of patient autonomy. The current dispute resolution mechanism(s) does not adequately consider evidence-based medical guidelines, standards of care, the patient’s best interests, expert opinion, or distributive justice. We discuss two cases adjudicated by the Consent and Capacity board of Ontario that demonstrate the over emphasis on patient autonomy. Current health care policy and the Health Care Consent Act also place emphasis on patient autonomy without considering other ethically defensible factors. We argue that current policy and legislation require amendment, and unless there are measures undertaken to modify them, both the quality of care provided and the long-term capabilities of the health care system to remain publicly-funded, comprehensive and equitable, are at stake.