PORTUGAL Trends and Developments Contributed by: Margarida Roda Santos, Paulo Sampaio Neves and Mariana Pereira Dias, Eversheds Sutherland
Regulatory matters Value-based healthcare
applies should start preparing for its application. Healthcare providers, manufacturers of medical devices and organisations carrying out research and development activities in relation to medi- cines – and which, due to their size and turnover, will be required to comply with NIS2 – should implement robust information security systems. Alongside NIS2, and reflecting the European Union’s concern, in January this year the Euro- pean Commission presented an action plan aimed at strengthening cybersecurity for hos- pitals and healthcare providers. The European Union intends to give high priority to this plan, as it is a fundamental step towards protecting the health sector from the various cyberthreats. The European Union is sensitive to the issues that digitalisation can cause, showing aware- ness that cyberattacks can delay medical pro- cedures, create bottlenecks in emergency rooms and disrupt vital services that, in serious cases, can have a direct impact on the lives of Europe- ans. Accordingly, the action plan has four main priorities: • reinforce prevention; • improve threat detection and identification; • respond to cyber-attacks in order to minimise their impact; and • dissuade the entities responsible for cyberthreats in order to protect European health systems. It is expected that the plan will be progressively implemented, this year and next, by healthcare providers, member states and the cybersecurity community.
With an increasingly ageing population, fewer specialised healthcare staff and growing ine- qualities in access to healthcare, the value- based healthcare (VBH) financing model is gain- ing greater prominence in Europe, as it makes it possible to constrain, and above all rationalise, healthcare expenditure. The VBH model is, in practice, a financing model centred on measurable results and incentives linked to quality. As its name suggests, the VBH model focuses on providing high-quality health- care with better-controlled costs, linking reim- bursement or payment to the outcome of the patient’s treatment. However, the concept of “value” is indetermi - nate, and it is difficult to quantify value in health- care since patients’ experience and treatment outcomes can differ. It is essential to devise study programmes to measure patient satisfaction throughout the treatment and recovery process, and thus pro- vide a baseline to determine whether a particular treatment falls below or exceeds the minimum acceptable threshold. In turn, this will make it possible to remunerate according to the value generated. The VBH model can aid the exchange of person- al data between healthcare providers, insurers and regulatory bodies. The GDPR, in this con- text, poses a challenge to the exchange of infor- mation, which must obviously comply with the applicable legal standards. This is clearly an area where innovation can thrive in the absence of regulation. Therefore, once again, there is a need to avoid complicating European and national rules, or to make them more flexible, in order
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