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Speeding up Implementation: From Innovation Through Regulation to Reimbursement

A report from the ESC Digital Summit 2019
5 and 6 October 2019, Tallinn, Estonia

Chairperson: Terje Peetso.

Speakers: Friedrich Koehler, Kitty Kubo.

Roundtable experts: Allan Bohm, Robert A. Byrne, Enrico G. Caiani, Donna Fitzsimons, Alan Fraser, Itzhak Gabizon, Damien Gruson, Zenichi Ihara, Magnus Jensen, Hareld Kemps, Gillian Leng, Rafal Samborski, Axel Verstrael.

Regulation and reimbursement underpin implementation of innovation into healthcare systems. In Germany, the traditional path from idea to product launch in the health sector takes 10 years on average. The digital era has ushered in a new system, and in 2015 the Innovation Fund was established. Around 120 new forms of care have been funded, of which six use telemedicine, telematics and e-health. A new law on better digitalisation and innovation (DVG) states that patients have a right to digital health applications. To get reimbursement for an app, providers must show positive care effects, but clinical trials are not mandatory. The law also enables health insurance companies to participate in start-ups (e.g. for app development).

Estonia is adopting an assessment framework for digital health from the UK National Institute for Health and Care Excellence (NICE). Evidence of effectiveness and economic impact is examined. Products deemed to provide value move to the reimbursement stage, while those that do not are removed from pipeline. Promising products go into the Innovation Fund whereby a grant or provisional reimbursement is provided to gather evidence through real-world data collection.


Discussion points

Where should innovative ideas originate?

  • Industry has the technology but does not know what the problems are.
  • Clinicians should identify the problems that need to be solved. Hackathons are a good place to present issues faced in everyday healthcare and ask technicians to find a simple solution.
  • Citizens are the best source of ideas and can push politicians to address problems.

How can digital technologies be assessed more rapidly?

  • We need to speed up effective innovation and the first step is to show that it will improve outcomes, save time and/or reduce costs.
  • Faster access to funding is required to assess the digital technologies.
  • Digital health innovations evolve. New methodologies are needed to test these updates and new versions. Lifelong approval for a product is a thing of the past.
  • Balance is needed between speeding up assessment but not giving approval before there is sufficient evidence.
  • There is scope for more interaction between developers, innovators, and regulators on what evidence is required. This is in place for drug developers and could be used for digital technologies.
  • EU countries should work together to develop methodologies for assessing digital technologies – for example how to use real-world data.
  • Health technology assessment could be shared by EU countries, which would then make individual decisions based on that evidence.

How can approval of digital technologies be accelerated?

  • Regulation can slow innovation to prime time, but it is needed to prevent ineffective or harmful technologies reaching the public. The ESC should help define what is important.
  • Conditional approval can accelerate use: safe and effective technologies introduced with the caveat that manufacturers collect more evidence. This was excluded from the EU medical device regulation but there is scope for notified bodies to give a provisional CE mark.
  • Regulators should become involved at the start of the development process to ensure the right evidence is collected for an idea. E.g. NICE has an online service called Health Tech Connect which helps companies build the right systems to collect data.
  • IT architecture requires regulation, similar to EU General Data Protection Regulation (GDPR). Currently, data can leave the borders of some countries, but not others.
  • GDPR inhibits companies tapping into real-world evidence, including nationwide registries, to train machine learning algorithms. It also generates trust and aids implementation when software is GDPR compliant, for example.

How can reimbursement in healthcare be updated for the digital era?

  • Governments and insurers need to change their decisions and processes. Helpful solutions like tele cardiac rehabilitation are not used if not reimbursed.
  • Reimbursement is problematic unless all stakeholders are involved in the decisions. E.g. cardiac rehabilitation speeds up return to work and benefits sick leave insurers but not health insurers.
  • Hospitals are risk averse and are less willing than doctors to take a chance on health insurance policies which enable quick reimbursement if innovations are effective.
    Inclusion of digital health solutions in clinical practice guidelines is an important way to pressure governments for reimbursement.
  • Guidelines and clinical evidence are insufficient for reimbursement. Political will is essential, otherwise a post code lottery emerges, even within countries. In Italy, some regions have a tariff for remote monitoring of devices and others do not.
  • Greater European harmonisation for reimbursement would help moving forward. E.g. telemedicine is reimbursed in France, but not in Belgium.
  • Patients should be at the heart of this process – we should use their voices to pressure politicians to reimburse digital health. They can articulate the importance of fair and equitable access to digitalised products that improve their outcomes and quality of life.
  • The European Commission published ‘Proposed guiding principles for reimbursement of digital health products and solutions’ which stresses the need for tailor-made methodologies and the selection of criteria for health technology assessment.
  • Innovation is needed in reimbursement so that it is not a retrospective process of being paid back. Today’s system does not incentivise efficiency gains.
  • What does value mean in digital health? Stakeholders need to collectively come up with clear definitions of value and success for digital technologies.

How can we improve implementation of digital solutions?

  • Funding is needed to help with starting up costs.
  • Lack support for implementation stops roll-out of innovations that were successful in one region to other parts of a country.
  • Products will be used if stakeholders interact from the start of the development process.



Digital health is rapidly evolving and requires agile methods and systems for assessment, regulation, reimbursement, and adoption. This will be helped by involving all stakeholders – patients, clinicians, industry, regulators, and reimbursement authorities – from idea to implementation.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.