Ethics

Key points Health data can drive better outcomes and support patient safety Total anonymisation would make secondary use of device or research data impossible MedTech Europe has developed a framework that balances data protection with data-driven opportunities to help perform the analysis of re-identification risks We live in an increasingly data-driven world. Innovative medical technology […]

By embedding compliance at the core of decision-making, medtech and life science companies will be ready to rise to future challenges When we think about the key trends shaping the healthcare sector, it quickly becomes clear that ethics and compliance have a central role to play in the future of our industry. Consider the risks […]

With new global challenges on the horizon, compliance with the MedTech Europe Code is an investment in the future  If my years as a legal and compliance professional in Europe’s medical technology sector have taught me anything, it is the value of trust. It is vital that healthcare professionals and patients trust us to produce […]

One of the strongest trends I have observed in healthcare over the past decade has been the growth of patient power. Patients are actively shaping their care like never before. In response, health systems and companies are increasingly focused on the outcomes and experiences that matter to patients. The voice of patients is also becoming […]

Bringing innovative medical technology to patients around the world is a priority for the medtech industry. This task often relies on a wide network of third-party intermediaries and distributors. While third parties provide valuable local knowledge, logistics and skills, it is important to appreciate that everyone working on behalf of medtech companies is bound by […]

I believe that data has the power to transform patient care. But do the legal and regulatory landscapes in Europe and around the world pose some sort of obstacle to digital health innovation in the medical technology sector? This is a hot topic right now as patients – indeed, all citizens – become increasingly aware […]

On May 25, 2018, the GDPR became effective across the EU, simultaneously resulting in a ‘consistent and homogenous application’ of data protection rules across the Union (per Recital 10 of the Regulation). For data protection professionals at medical technology companies, the clarity brought by the GDPR has meant that resources can be redirected towards ensuring […]

This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities, the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes […]

In an era where transparency is expected, the healthcare industry has been at the centre of attention from the public and from authorities. We can see this in how governments around the world – notably the US and France – have developed ‘Sunshine Acts’ to mandate disclosure of industry support for healthcare institutions and professionals. […]