Healthcare regulation: What's next?

Web content editor Ian Bolland visited the University of Manchester’s Healthcare Disparities: Disruptive Healthcare Technologies and the Patient Event. Here, he highlights two key points brought about from two days of lectures.

The event focussed on the patients who had access to healthcare, technologies and the standard of healthcare given – and those whose access was limited.

The two days of lectures held at the University of Manchester’s School of Law also contemplated two key areas: Brexit, with the deadline for the United Kingdom to withdraw from the European Union of 31 October looming large; as well as how regulation keeps pace with advancements in technology in healthcare.

Despite the UK’s continuing membership of the bloc, after it deferred the initial 29 March withdrawal date Theresa May had planned after triggering Article 50 in 2017, Professor Tamara Hervey from the University of Sheffield explained the effects that a Leave vote has had despite the UK’s membership lasting longer than anticipated.

She outlined that the European Medicine Agency’s decision to relocate from London to Amsterdam, and the “highly unlikely” decision to return was one effect, while biomedical research teams were said to be “frozen out.”

But she stated that any harm would vary depending on the type of Brexit, saying: “In brief the withdrawal agreement is much less harmful than a no-deal Brexit. Remain would be the best option overall for health and the NHS.”

Questions were raised as to the UK’s readiness for an exit if a withdrawal agreement wasn’t ratified by Parliament, though Professor Hervey noted the longer the delay, the more ready the country would be for a no deal because of more preparation time.

There are questions that remain to be answered – what happens to cross-border contracts in the event of a no-deal Brexit given the inevitable supply chain effect? If the Northern Ireland protocol were to be adopted – the so-called backstop – the supply of devices and medicines across the island of Ireland is likely to be unaffected.

The focus on law and regulation in healthcare wasn’t just limited to the UK – or related to settling its current constitutional deadlock.

While Professor Nicolas Terry from the University of Indiana mainly argued that disruptive technologies have the potential to make improvements regarding disparities and discrimination – as well as the opposite in terms of benefiting the more affluent – he said that the speed at which AI is being developed within healthcare can’t be overestimated. As such, it presents a challenge for the regulators to keep pace with the rate of innovation.

There was one overriding theme to the questions following his presentation: do you fix technology regulation or do you fix the healthcare system? Though his presentation largely referred to the US system, plenty of the substance applies elsewhere – including the UK and Ireland.

Professor Terry said: “As healthcare technologies from apps to robotics and AI develop faster than conventional healthcare can reinvent itself, disruptors will not only avoid innovation sapping third party reimbursement in the US but also the complex regulatory structures faced by healthcare companies. In other words, they will be able to practice regulatory disruption as well as business disruption.

“The question is how do we go about regulating these technologies? Do we go with an AI super-regulator? And wrap all the technologies together and have it done that way? Or do we go piece meal and do it by domain?   

“You need to build regulation on law on top of ethics so what are the applicable moral and ethical approaches to AI?”