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Focus on Regulation

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective partnerships

DigiHealth Leaders ConferenceDigital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU.

The two daylong DigiHealth Leaders conference featured presentations, panel discussions and roundtable conversations on topics viewed as hurdles to the realisation of digital health’s potential. Hein van den Bos, a Partner in our Amsterdam office, delivered a presentation on how to navigate the EU and Member States’ regulatory approaches to digital health, and Jane Summerfield, Counsel in our London office, moderated a panel discussion on gaining traction and navigating regulatory pathways when scaling across borders.

Here we discuss a selection of the prevailing themes that were present throughout the conference.

Interoperability; the right data, to the right person, at the right time

The starting point for achieving widespread digital transformation was identified as interoperability of data and system infrastructures. Currently, the healthcare industry is heterogeneous and fragmented; doctors, pharmacists, hospitals, and industry all generate data and store it on their own databases, which are rarely shared. By ensuring interoperability, health records from every source could be assessed holistically, delivering better patient outcomes and introducing efficiencies and cost savings.

Scepticism around potential collaborators’ intentions is widely cited as the main reason behind the reluctance for players to share their data. One panel member succinctly surmised “your product may be proprietary, but your market is not“.

There was a general consensus that any technology-driven shift in the healthcare sector must be government-backed. In this regard, progress is being made, for example, the US 21st Century Cures Act calls on health IT developers to publish ‘application programming interfaces’ and allow health information from such technology to be accessed, exchanged and used without special effort. The Act also introduced penalties for information blocking, defined as measures which are likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.

Similarly, in February this year, the EU published a Recommendation on a European electronic health record exchange format, in order to achieve secure, interoperable, cross-border access to, and exchange of, electronic health data in the Union. It is hoped that the use of secure electronic identification and authentication will enhance security and confidence in electronic patient data systems.

Reimbursement; better outcomes for the many not the few

Purely digital solutions are attractive investments as, in comparison to pharmaceuticals and biotechnologies, they are low cost and have the potential for wide dissemination via personal smartphones. However, their assimilation into modern healthcare has been tentative. This is partly due to the fact that, payers have not been particularly receptive to the idea of reimbursing a digital healthcare solution, meaning that a large proportion of the digital healthcare market is self-paid.

Despite the lack-lustre embrace, there are signs that payers are starting to recognise the benefits that digital technologies can provide, and reimbursement initiatives are slowly developing. For example, earlier this month, the German parliament passed a new law enhancing digital healthcare provision for patients. Under the new law, reimbursement will be granted for digital health solutions that are medical devices of a low risk class (Class I or IIa). For more information, please see our German colleagues’ blog here.

Further, in September 2018, the UK’s NHS introduced the Innovation and Technology Payment, which “aims to remove financial and procurement barriers to support the NHS to adopt innovative medical devices, diagnostics, and digital products“. Under this regime, innovations are subjected to a competitive process which, if successful, allows healthcare providers to order innovations directly from the supplier at no cost and NHS England reimburses the supplier directly.

Patient centricity and digital phenotypes

Digital healthcare solutions have huge potential to improve the patient experience and provide efficiencies to healthcare organisations. For example, many apps have been developed which allow patients to track their metrics without attending clinics, which reduces the need for follow-up appointments and could dramatically reduce the burden on healthcare organisations.

One presenter commented that health data should be more like our financial profiles; our digital phenotypes should wrap around us and follow us wherever we go. By doing so, patients can become active partners in the management of their own care. With more engaged patients, compliance with treatments will improve, leading to better patient outcomes.

A key hurdle to realising this aim will be to make sure that patients feel safe; transparency in processes, data protection and patient autonomy must be ensured. One panel member commented that “you can only lose trust once“. In this regard, it will be key for patients to know what data is being collected, why it is being collected, how it will be synthesised and what benefit this has to the patient and to society as a whole.DigiHealth Leaders Conference

Forging effective partnerships

Given the broad range of attendees at the conference, from venture capitalists, to insurance companies, start-ups and big pharma, various discussions were had around how to cultivate effective partnerships. Certain tips were offered, those which were best received are listed below:

  • Partners should align their expectations; a clear problem statement and scope of work for what the partnership seeks to achieve should be agreed.
  • Indicators of progress and traction should be clearly defined. Start-ups were advised to offer packages in a manner that is equivalent to what the incumbent pharmaceutical companies are used to working within, for example, proxys to regulatory approval, and pricing and reimbursement decisions.
  • Partners should recognise each other’s strengths; large pharmaceutical companies have sophisticated regulatory and legal teams which are well equipped to navigate very structured regulatory systems, whereas start-ups offer innovation, agility and enthusiasm.
  • Start-ups were advised to find a champion within their partner company to assist them in navigating the internal structures, and introducing them to the right people.

Governments, regulators, industry and the public are warming up to the idea of digital healthcare; changes might be incremental, but they are being made. The number of start-ups and investors in attendance at the DigiHealth Leaders Conference demonstrated the interest in, and excitement around, this burgeoning industry. It is just matter of time before the digital transformation clicks into action, but as one panel member put it, “the genie is out of the bottle“.