Voice Assistants in Pre and Post-Operative Care and the Duty to Warn Patients of Remote Risks – A Legal Discussion
This guest post is an edited extract from Voice Technology in Healthcare, Chapter 14, The Laws of Voice, by Bianca Phillips, an officer of the Supreme Court of Victoria, Australia and Heather B. Deixler, a senior associate at Latham & Watkins LLP.
Voice assistants will increasingly provide patients with pre- and post-surgery information. The information may be of a general nature, or the skill could be more personalized. If a potential risk of surgery is so remote that it is rarely seen in practice, and only appears in archaic medical literature, does the voice assistant need to advise of that risk?
Imagine the following hypothetical scenario. A patient, Stacey, is about to undergo cataract surgery. In the pre-op appointment, Stacey’s surgeon highlights the risks of surgery and, in her concluding remarks, advises Stacey that “you may also consult your voice assistant to learn more about your surgery, and ask questions about the risks and post-op process.”
That evening Stacey goes home and says to her voice assistant (VA) “[VA name], what are the risks of cataract surgery?” The VA responds “the risks of cataract surgery include: Posterior capsule opacity (PCO), Intraocular lens dislocation, Eye inflammation, Light sensitivity, Photopsia (perceived flashes of light), Macular edema (swelling of the central retina), Ptosis (droopy eyelid) and Ocular hypertension (elevated eye pressure).” Stacey continues to ask a range of questions about post-operative care and the recovery process.
Surgery seems to have gone well. However, two months after the surgery Stacey advises her doctor of considerably decreased vision in her left eye, which the surgeon determines is sympathetic ophthalmia. The estimated post-operative occurrence is between 0.01%–0.05%. Attempts to treat the sympathetic ophthalmia fail and the patient sustains a permanent loss of vision in her left eye. The surgeon failed to inform Stacey of the risk of sympathetic ophthalmia during the pre-op consultation, and Stacey’s VA also did not inform her of this risk. Stacey wants to know whether the surgeon and/or the VA had a duty to inform her of the remote risk.
Torts Law: The Duty to Warn & Standard of Care
In order for a physician to obtain informed consent, the physician must notify patients of risks, benefits, and alternatives to treatment. The law generally requires that only “reasonably foreseeable” material risks be disclosed. The law of tort includes a duty for individuals and entities to warn of risks of treatment. If knowledge of the risk could affect the patient’s decision to progress with the treatment, then it may be determined that there was a duty to warn the patient. While certain courts rely upon the community disclosure standards (i.e., whether the majority of physicians in a certain community would customarily disclose this), other courts look to whether it would be reasonable under the circumstances to make such disclosure.
An interesting legal question surrounds the standard of care that will be expected of VA developers and manufacturers. Could the VA and the company that developed it be held to the same standard of care as a physician? What if the VA and surgeon had responded in a more general manner? That is, “the risks of cataract surgery include inflammation, infection, bleeding, swelling, drooping eyelid, dislocation of an artificial lens, retinal detachment, glaucoma, secondary cataract and loss of vision.” The loss of vision is now on the list. This is the outcome that the patient in the above scenario experienced. The disclosure now includes a wider range of potential risks, which arguably covers that patient’s experience and grievance with their doctor and the VA.
Considerations for VA Developers of Healthcare Applications
If you are a healthcare Voice application developer the following questions may direct discussion points amongst colleagues and legal advisers. Consider the following sample of questions turning to the question of responsibilities within the domain of torts law:
- What types of disclaimers should the VA include to shield itself from liability?
- When should the VA refer the patient back to their clinician for more information about risks specific to their circumstances? Further, what triggers should be built into the VA to ensure that this referral takes place?
- To what extent is the VA operating independently of the physician versus as an extension of the physician’s practice?
- Could the VA be considered to be engaged in the unauthorized practice of medicine?
- Should the patient or consumer receive a transcript of the conversation with the VA, or a summary of “advice” that they can maintain?
- What types of records should be maintained?
There is a range of legal considerations relating to voice assistant use within healthcare services. The preceding discussion has highlighted a few of these considerations within the domain of torts law and is designed to get you thinking about your role in shaping the future of law and society.