Patient outcomes data form the core of digital health. Patient data are collected, shared, analysed, and leveraged to pioneer innovative therapies, diagnostics, and prevention tools.
We guide clients through the landscape of laws and regulations that govern a digital health technology across its entire life cycle, from conception and development to validation, market launch, and the post-market phase. These services include advice on product qualification, safety and efficacy requirements, clinical studies, data protection strategies, interactions with patients and healthcare practitioners (to ensure compliance with therapeutic freedom, medical confidentiality, and advertisement restrictions), reimbursement pathways, post-market surveillance and reporting requirements, and use of real-world data.
We assist clients in putting in place the appropriate contractual arrangements to manage the relationships with their partners, preserving the freedom to operate the technology, and strengthening their IP position.
Further, we offer rigorous legal due diligence assessments of both the digital health technology and the affiliated company. This assessment evaluates compliance levels, intellectual property safeguarding, and personal data protection. We deliver a comprehensive gap analysis report and a clear roadmap to achieve full compliance, actively assisting our clients in its implementation.
Quinz’s Digital Heath practice team operates across various domains, including telehealth & telemedicine (remote monitoring, consultation & medical care), e-health (including e-health platforms and e-health records), m-health (medical, fitness & wellbeing applications), devices, sensors & wearables, and digital therapeutics.
Recent work highlights
- Quinz advised a US-based digital health company, on the validity under the Belgian regulatory framework of an online app that enables patients to measure their eye strength without the intervention of an ophthalmologist.
- Quinz assisted in the acquisition and regulatory assessment of an innovative digital health platform that connects patient volunteers with available clinical trials, on a worldwide basis. The regulatory assessment conducted by Quinz focused primarily on potential regulatory and privacy issues surrounding such platform and corrective / preventive action plans to ensure compliance.
- Quinz assisted a multinational pharma company, in setting up a platform for patient data for HTA purpose. We advised the client on the platform structure to ensure full compliance with the laws and regulations on clinical trials and GDPR. Furthermore, our team assisted in the negotiation of the software development and license agreement, data processing agreement, and the drafting of all policies and general terms and conditions for the use of the platform.
- Quinz assisted a German based telemedicine company in the commercialization of its digital health technology (medical device). We advised the client on the commercialization model to ensure compliance with the principles of therapeutic freedom, medical confidentiality and protection of personal data, and on how to communicate with patients and organize payment streams to ensure compliance with advertisement restrictions.
- Quinz assisted a Dutch company implementing an international e-health platform (including the online purchase of prescription drugs). Quinz advised the client to ensure that the e-health activities are conducted in strict compliance with applicable regulations and standards under Belgian and EU law.
