Medical Accountability in the Digital Health Era

The doctor was trusted and dominant. The patient was uninformed, grateful, and believed in fate. The patient presumed that good intentions, good training, and good facilities, automatically lead to good results. Amicability was mistaken for quality control. If something went wrong, patients often would not know, and if they did, they would not complain. That was the generation when I trained - the 20th century.

In 2024, in the Digital Health Age, there are no presumptions. The increasing complexity of modern healthcare leads to more opportunities for error. Access to a superspecialist today, is only a mouse click away. Today’s doctors practicing Digital Health deal with quality control, audits, protocols, regulations, guidelines, and frequent inspections.

The patient has become a consumer – a hard negotiator, buying a product, calling the shots, and playing an important role in changing the system.

In a play, actors must recite the lines written for them. In a musical, the singers cannot choose their tunes. Will the Digital Health (DH) care practitioner be held accountable if a standard approved evidence-based algorithm is not implemented?

To quote Deming “Customers who use a product, should have a say in its design” and "It does not count unless you can count it." Doing the right thing and doing the right thing right are today’s buzzwords.

Continuous Quality Improvement techniques used in monitoring industrial processes are now used in tracking patient care. Hospitals are also in business - to make products - patients who are cured. While a factory takes pains to assure that the end product is consistently perfect – a Sigma Six – all hospitals do not. The health consumer is trying to ensure that customer delight, not satisfied doctors, is the new slogan for the healthcare industry.

The hackneyed phrase “clinical judgment” is giving way to standardization of care with a view to consistency and predictability. There is always a gap between the scientific evidence about what works best and the care a patient actually receives. A doctor may follow the results of one study, disregard the findings of a second, and be unaware of a third.

Today a patient says, “We think you are good quality; you’ve assured us you are good quality – now we ask you to prove it”. This is indeed a quantum leap forward so far as accountability is concerned.

Medical Accountability should not be viewed as displacing the physician from the pedestal, he has been sitting on for centuries.

“Come, give us a taste of your quality,” said William Shakespeare, in Hamlet, four centuries ago. Today’s DH clinicians will have to work overtime and prove to the world that they indeed deserve the pedestal.

Integration of DH technologies into clinical practice has introduced significant challenges and opportunities regarding medical accountability. This includes -

a) Uncertainty of Responsibilities among healthcare professionals when utilizing DH tools. This hinders effective communication and shared decision-making, critical to patient care. 

b) Legal and Ethical Dilemmas: Rapid evolution of DH technologies outpaces legal and regulatory frameworks. When a digital tool contributes to a medical error, quantifying the concept of shared responsibility among clinicians, technology providers, and healthcare institutions would depend on a contextual interpretation. Malpractice claims are judged against "customary medical practice" which is just evolving with DH.

c) Data Privacy and Security: The potential for data breaches and misuse of personal health information is a critical issue. The precise liability of the clinician is yet to be addressed.

Moral accountability is different from legal liability. Clinicians do not exercise direct control over recommendations generated by a system. Often a clinician does not even understand how a system translates input data into output decisions.

An analysis by a US-based professional liability provider found that 66% of telemedicine-related claims between 2014 and 2018 were related to misdiagnosis.

In a recent survey of 242 clinicians in Pakistan, 69% ‘agreed’ or ‘strongly agreed’ that there is a ‘lack of regulation to avoid medical malpractice’. Only 29% believed that their medical indemnity would cover telehealth consultations.

Several authors have suggested the need for greater competency-based, outcome-oriented education including sessions on “Accountability” related issues in the deployment of DH.

Contactless sensors, including depth, thermal, radio, and audio sensors are increasingly integrated into surgical equipment. This creates a level of ambient intelligence within the operating rooms of the future. Huge volumes of data will be available for retrospective analysis of events, in a malpractice claim review, to assess surgical competence. Clinicians in the West, are advised to review their individual malpractice liability policies, before utilizing DH technology.

It is often argued that premature regulation would stifle innovation and competitiveness and that governments lack the flexibility or understanding to regulate effectively. This communication raises questions. Worldwide, solutions suggested are yet to be tested.

DH no doubt can improve the quality of life of millions of people around the world. We are in a state of transition. All transitions offer great opportunities to take preventive measures. Understanding what exactly constitutes accountability in the deployment of DH, for each of the multiple players in an ever-growing complex healthcare ecosystem is a vexing problem.

The answer will always be contextual. Healthcare including DH is not mathematics. It will never ever be black or white. It will always be various shades of grey. Ultimately we will resort to the centuries-old judicial cliches “caveat emptor” and “res ipsa loquitur”.