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Sharon Lamb focuses her practice on health care transactions, investments and projects, as well as comprehensive health care regulatory advice. She has advised private and public health care clients for more than 17 years. Click here to read Sharon Lamb's full bio.

A recent McDermott roundtable on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identified opportunities for companies and investors.

Digital health solutions are widely considered to be the next big growth market. Healthcare lags significantly behind other industries when it comes to digitization, but the potential opportunities are driving developers, healthcare providers, and investors to find solutions.

PATIENT CARE
A key point to bear in mind about healthcare technology is that success and adoption may often be measured by the quality of the users’ experience, the resulting clinical outcomes, short and long term cost savings, and the resulting margin for both investors and the health care system at large. These multi-faceted goals are best illustrated by the demands for i) greater efficiency, and ii) better patient outcomes.

Efficiency is typified by, for example, streamlined bookings and appointment reminders, algorithms that triage patients to ensure they are seen by the right person at the right time, and in-home patient monitoring after patients are discharged. Patient take-up is also an excellent gauge of efficiency, for example, a high tech product that measures and reports blood sugar is of no value if the interface is too complicated for an older population.

Better outcomes result from clinicians gathering and using data to determine the right treatment in the fastest possible time, and are demonstrated, for example, by permanent lifestyle changes, improvements in self-care or care outside hospital,accurate drug dosage and use of medicines, and, in direct contrast with other sectors, reduced, rather than increased, service usage.

PRIVACY AND REGULATORY HURDLES
One of the most obvious challenges inherent in digital health is data privacy and security. Stemming from that are issues relating to control of the data, the right to use it, and ownership of the analysis. The most successful companies are those that, from the very beginning, understand the regulatory landscape in which they are operating; are transparent in terms of where their data comes from; make clear the type of data at issue, be that identifiable, pseudonymized, anonymized, or something in between; and identify who will control what data in what form. The ability to marry up these factors is a key part of any new entrant’s value proposition.


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Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices.

Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI.

At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a way behind.

In May 2020, the new MDR will change the law and process of certification for medical software. The new law includes significant changes for digital health technologies which are medical devices. In March 2019, the National Institute for Health and Care Excellence (NICE) also published a new evidence standards framework for digital health technologies. The Care Quality Commission (CQC) already regulates online provision of health care, and there are calls for wider and greater regulation. The government has also published a code on the use of data in AI.

Digital Health Technologies and the MDR

The new MDR will mean a significant change to the regulatory framework for medical devices in the European Union.

As with the previous law, the MDR regulates devices through a classification system.

The new regime introduces new rules for medical software that falls within the definition of device. This will mean significant changes for companies that develop or offer medical software solutions, especially if their current certification has been “up-classed” under the MDR.

Key Takeaways for Investors in Digital Health Tools

Companies and investors in digital health should:

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