Vincent Buscemi’s, Partner and Head of Independent Health and Social Care at Bevan Brittan LLP, reflections after chairing the ‘Bringing Innovation into Healthcare’ panel at Laing Buisson’s Private Acute Healthcare conference  

We are currently seeing a rapid acceleration in the pace of innovation and new technology in health services globally – driven largely by digital investments.

A report* this week said that the size of the global digital transformation healthcare market would grow from USD 76.34 billion in 2018 to an anticipated USD 210 billion by the end of 2025 – driven by higher penetration of smartphones and the adoption of cloud technology.

The increased demand for health monitoring digital devices, and improved data analytics to better manage population health, comes as public health resources come under huge strain – with aging populations and an increase in a number of chronic diseases, such as heart disease, diabetes and dementia, being major factors.

But there is frustration at the pace of change, and there is a need now for regulators, authorities and clinicians to work together in bringing new technology more quickly to the front line of healthcare.

NHS’ new ‘fast track’ route

In the UK, the government has announced a new fast-track route into the NHS for “breakthrough” medicines and technologies to speed up the time it takes for patients to benefit from ground-breaking products for difficult medical conditions. The ‘accelerated access pathway’ means that products with the greatest potential to change lives could be available up to four years earlier.

It is being done by reducing the time it takes to negotiate, evaluate and obtain financial approvals before the NHS can purchase the products. Under the scheme, a number of products each year will receive ‘breakthrough’ designation.

This will unlock a package of support allowing firms to accelerate clinical development and gain a fast-track route through the NHS’s approval processes. Further improvements mean the most promising medicines, diagnostic tools and digital services will go through the clinical development and regulatory approval process even faster.

The newly named Accelerated Access Collaborative (‘AAC’) is now the new umbrella organisation for UK health innovation. It will act as the ‘front door’ for innovators looking to get their products funded by the NHS and will provide support to overcome barriers that can prevent the best medical innovations from reaching patients.

Could data safety and security stifle growth?

Elsewhere, however, there are concerns that patients’ data safety and security may hinder innovation and market growth. The increasing ability of technology to enable new platforms to deliver care via new models, and frequently on a remote and cross-border basis, is a massive challenge for regulators to ensure the quality and safety of such new models of delivery.  

Many countries are aiming to break down boundaries between hospital care, primary care, community and social care to provide more person and place based services that are increasingly seamless. The challenge for regulators is to properly combine the task of carrying out system-wide reviews whilst ensuring the accountability of the individual players.    

In some jurisdictions, over regulation and the competing interests of multiple agencies can create inertia, silo working, and regulatory gaps. Clear regulatory structures are therefore essential, not only in terms of efficiency but also promoting safety and quality.

One area of concern is remote dispensing. Increasingly, patients are obtaining medicines from international sources potentially without sufficient advice and expertise from qualified professionals. There is uncertainty how regulators can monitor the quality and safety of drugs obtained via the internet.

Inspections of health services are a mainstay of regulatory performance, but factors affecting quality can also be assessed from data. However, multiple definitions and metrics of care quality are often used by different agencies, leading to inconsistencies and inefficiencies for providers in meeting information requests. There is a need to reduce the burden on providers with more streamlined systems that, for example, make use of shared data sets that address the needs of all stakeholders.

The big picture remains positive

New entrants from outside the traditional business of healthcare are redefining the global healthcare market in both developed and developing nations, bringing more affordable and convenient care options, wellness and fitness to address longstanding challenges.

Closer links are developing between the public and independent sectors – in which medical expertise, capability and facilities help generate vital extra capacity and funding options for hard-pressed national health budgets through economies of scale and improved access – leading to better patient outcomes and an improved patient experience.

But with increased medical tourism and more global centres of expertise, regulators need to be able to work jointly on a cross jurisdictional basis, sharing best practice and having a consistent approach to issues and emergencies to ensure that in bringing innovation into healthcare is done within a risk based framework that does not jeopardise the safety of patients.

For further information on how Bevan Brittan can help your organisation deliver innovation within your services, please visit www.bevanbrittan.com/independenthealth.


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