In Part 1 of this series (Consent in Healthcare: Outline, Gaps and Conundrum), we presented a brief regulatory background on informed consent in healthcare in India, as well as judicial pronouncements on the topic. We also focussed on specific methods of obtaining consent as prescribed by such regulations.
In this section, we’ll look at the practical implications of such legislations and rulings, particularly in the context of telemedicine and digital health, as well as instances in which the patient is unable to provide consent.
Consent in Emergencies
As discussed in Part 1, multiple legislations, regulations, and judicial precedents elaborate upon the concept and requirement of consent. Despite this, in many cases, the requirement of informed consent for medical treatments and procedures is still based upon the professional judgment of healthcare practitioners. Emergency situations, such as those involving accident victims, are an excellent example of this.
This isn’t to say that there aren’t any legal principles that can help us. In fact, there have been judicial pronouncements that establish the fundamental norms that must underpin any practice adopted in this area. Briefly, these are as follows:
(a) Every doctor is professionally obliged to extend his or her services to protect the life of an injured person, brought to them for treatment, and that ‘no law or state action’ can intervene to avoid or delay the discharge of this duty. The court further went on to clarify that the obligation to treat an injured person, being total and absolute, would override any laws of procedure, which may interfere with the discharge of this obligation;
(b) In case a seriously injured patient is brought in and emergency treatment needs to be administered, there can be no question of waiting for consent of the patient or from the person who brought the patient to the hospital. Thus, it was not necessary to wait for consent before beginning treatment. It was further held that consent is implicit in such emergency cases when a patient is brought to the hospital for treatment. In fact, a surgeon who fails to perform an emergency operation must prove that the patient refused to undergo the operation not only at the initial stage, but also after he or she was informed of the dangerous consequences of not undergoing the operation;
(c) During emergencies, where a doctor cannot wait for the consent of his patient or where the patient is not in a fit state of mind to give consent, surgeons cannot say they didn’t operate on the patient because of lack of consent. When a doctor advances a plea that the patient did not give consent to a surgery or for a course of treatment advised to him, the burden is on the doctor to prove that the non-performance of the surgery or the non-administration of the treatment was on account of the refusal of the patient to give consent thereto. Even if a patient is fit to give a voluntary response, a surgeon is duty-bound to inform him of the dangers or the risks involved in going without an operation. The court also observed that certain sections of the society maybe averse to the idea of a surgery initially, but may give consent when explained of the consequences of their preferred course of action. The court also quoted the following passage from ‘Law and Medical Ethics’ by Mason and McCall Smith: “As a general rule, medical treatment, even of a minor nature, should not proceed unless the doctor has first obtained the patient’s consent. This consent may be expressed or it may be implied, as it is when the patient present himself to the doctor for examination and acquiesces in the suggested routine. The principle of requiring consent applies in the overwhelming majority of cases, but there are certain circumstances in which a doctor may be entitled to proceed without this consent — firstly, when the patient’s balance of mind is disturbed, secondly, when the patient is incapable of giving consent by reason of unconsciousness; and, finally, when the patient is a minor”; and
(d) A patient needs to be apprised of the risks involved prior to getting into surgery, or in a particular course of treatment, before giving consent. When the patient is under general anaesthesia, the said patient can neither understand the risks involved, nor give consent.
Based on the above, it may be surmised that the law does provide some amount of guidance, combined with a level of flexibility, to healthcare service providers when it comes to consent requirement in emergency or accident cases. However, all of this is case specific, and the personnel who are tasked with dealing with such situations have to unravel the legal complexities and take decisions in real time.
For instance, what must be done when an accident victim is brought to a hospital, but refuses treatment (or some parts of the same). Should the doctors accept such refusal, or proceed with the treatment on the assumption that the victim is not in a fit state of mind. In both cases, doctors may be called upon to explain the basis of their decisions, including their assessment of the patient’s state of mind. This is despite the fact that in the Parmanand Katara judgment, the Supreme Court had called upon lawyers to honour persons in the medical profession and see to it that they are not called to give evidence so long as it is not necessary.
There are no easy answers when wading into such tricky waters. Each emergency has different medical implications. The victim may reach the doctor/ hospital alone, with passers-by, or with acquaintances and family. He may still be in a position to converse and give consent. Also, he may be conscious, but trauma may cloud his judgment. Amid all this, a doctor is expected to take decisions, taking into account the interplay of all of the above factors, with time being of essence, and a possibility of being dragged into courts regardless of what he decides to do next. And this is only a preliminary procedural issue, with the actual treatment and application of his expertise yet to commence.
As a mitigating mechanism, at the very least, doctors and hospitals must obtain from patients their refusal for treatment in writing (and as recommended in the Law Commission of India’s “201st Report On Emergency Medical Care To Victims Of Accidents And During Emergency Medical Condition And Women Under Labour”). Further, from a policy perspective, instead of subjecting medical practitioners to undue scrutiny, they must be granted a privileged legal standing, especially in relation to aspects of their profession, such as informed consent, which is still not clearly codified.
Consent in Telemedicine Scenarios:
As discussed in Part 1, the Telemedicine Practice Guidelines, 2020, provide guidance on the requirement of taking informed consent from patients who wish to avail of medical consultations/ services via telecommunication platforms. However, issues associated with data security and privacy may pose major challenges, especially with the explosion in digital health and telemedicine platforms.
The physical gap between the doctor and the patient mandates reliance on electronic tools for receiving and recording consent. But these tools can also be manipulated. In such a situation, a doctor providing his services also cannot conclusively confirm the identity of the person giving consent and receiving treatment. While telemedicine services, at present, are limited to ordinary and commonplace treatments, any fallout of the above discussed activities would be relatively moderate. But an expansion of the scope of telemedicine services in the future will require applicable regulations to cater to such issues.
Medical treatment cannot be provided by doctors and hospitals without informed consent. However, subjective discretion of the attending doctor comes up quite often given the regulatory framework surrounding consent. This must be remedied at the earliest. Clear procedures must be adopted in each specific fact scenarios. And where the doctors are still called upon to exercise their judgment, the benefit of doubt must accrue to them alone.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas