Belgium advances digital health as its Parliament calls for action

The Belgian Parliament's House of Representatives (HoR) has adopted a legislative resolution aimed at enhancing the accessibility and affordability of digital health applications (the Resolution). The resolution passed on 3 September underscores the importance of digital health solutions, especially in the wake of the Covid-19 pandemic, and calls upon the federal government to take decisive action.

The rise of digital health

The Covid-19 pandemic has significantly accelerated the adoption of digital health solutions worldwide. In Belgium, the necessity for remote consultations and telehealth services became evident as traditional healthcare systems faced unprecedented strain.

The HoR acknowledges that digital health applications, although previously underutilised, have now become integral to patient care, providing continuity of services while reducing the need for physical consultations. 

Scope and impact of the Resolution

The new resolution follows the implementation of two significant federal initiatives in support of ehealth: the eHealth Plan 2013-2018 and the eHealth Plan 2019-2021. Both action plans laid the groundwork for the digital transformation of healthcare in Belgium, focusing on multidisciplinary collaboration and the integration of mobile health (mHealth) technologies. The HoR stresses that the 2013-2018 plan achieved 72% of its objectives, setting a strong precedent for continued efforts in digital health.

In terms of legislative impact, the resolution stresses that any future legislative effort in support of eHealth should be in strict compliance with the General Data Protection Regulation (GDPR) of and the Belgian law of 30 July 2018 concerning the protection of individuals with regard to the processing of personal data. 

However, the resolution remains silent as to how Belgium intends to address the impact of artificial intelligence (AI) and the new, far-reaching AI regulatory framework. It does not address the situation of (med)tech of pharmaceutical businesses facing notified bodies' bottlenecks and tightened CE-marking requirements when launching digital therapeutics or other health software technologies.  

Current state of digital health in Belgium

The HoR resolution includes several critical requests directed at the federal government, aiming to bolster the digital health landscape in Belgium.

Firstly, the government is urged to make accessible, affordable, and high-quality digital health a priority, with particular attention to vulnerable groups. This includes ensuring that all patients, regardless of their socio-economic status, can benefit from digital health innovations. 

Secondly, the resolution calls for the Federal Centre of Expertise in Healthcare (KCE) to conduct research on the implementation of digital health solutions, focusing on their benefits for the healthcare system, patients and healthcare providers. This research is expected to provide valuable insights into the effectiveness and efficiency of digital health applications. 

Thirdly, a trajectory for increased investment in digital health is requested, emphasising the need for more significant portions of the federal healthcare budget to be allocated to digital health research, innovation, and practical implementation. This investment is identified as being crucial for transitioning to an integrated healthcare system that leverages digital solutions. 

Fourthly, the resolution flags the necessity of a comprehensive legal framework governing the use of digital health applications. This framework should address data processing and security in compliance with the GDPR, the prescription of digital health applications by physicians and the legal basis for their reimbursement. Key elements include:

• Allowing physicians to prescribe digital health applications that meet specific validation criteria (in accordance with the system set out by mHealthBelgium). 
• Reimbursing digital health applications that demonstrate added value in terms of accessibility, therapeutic adherence, and outcomes. 

Lastly, inspired by Germany's "Fast-Track-Verfahren," the resolution proposes a system to expedite the approval and reimbursement of digital health applications whose socio-economic value has yet to be demonstrated. This system should include a detailed guide outlining the procedure, application process, and evidence requirements, fostering collaboration with mHealthBelgium, the Belgian healthcare regulator FAMHP, the Belgium reimbursement authority NIHDI and the eHealth platform.

Osborne Clarke comment

The Belgian Parliament's recent resolution is a pivotal move towards embedding digital health solutions within the national legislative framework. By focusing on making these solutions more accessible and affordable, it aims to overcome significant barriers that have previously hindered their widespread adoption. 

This legislative push underscores the importance of digital health, especially post-pandemic, and calls for increased investment and a robust legal framework to support these innovations. The resolution also highlights the need for compliance with data protection laws, ensuring that patient data remains secure while fostering innovation. However, it falls short in addressing the challenges posed by healthcare AI and its new regulatory framework, as well as the bottlenecks and tightened compliance requirements currently faced by medical device (software) businesses.

For companies in the pharmaceutical, biotech, medtech, and digital health sectors, this resolution signals new opportunities for investment and collaboration. The proposed fast-track approval system for digital health applications could significantly reduce the time to market for innovative solutions, making it an opportune moment to engage with new funding streams and research initiatives. 

Additionally, the emphasis on a comprehensive legal framework provides clarity and security for digital health applications, encouraging companies to stay informed about regulatory developments to ensure compliance and leverage new opportunities for application prescription and reimbursement. As the digital health landscape evolves, building relationships with key stakeholders and investing in compliance will be crucial for seamless integration into the healthcare system. 


For tailored advice and strategic guidance on navigating these developments, our team at Osborne Clarke is here to support you.