We are delighted to launch the first issue of Mid-Year Digital Health Review, looking at key developments in the digital health market. Areas covered include upcoming regulatory developments for medical devices, what the EU has in store for the regulation of Artificial Intelligence, the use of wearables and apps in the fight against COVID-19 and the changing consumer law landscape and how it will effect digital health companies.
Commenting on the launch of Issue One, Michaela Herron, Product Regulatory & Liability Partner with Mason Hayes & Curran LLP, said “Digital health technology is developing at a lightning-fast pace and has the potential to transform healthcare systems for the better. As digital health solutions such as health apps, diagnostic software and wearable medical devices are adopted, it’s key that all stakeholders are up to speed with any new regulatory framework or legislation so they are fully compliant.”
The first issue of the Digital Health Review includes a useful step-by-step guide to the key phases for launching a health app in the EU, from initial idea to the post-launch phase, along with an overview of the legal and regulatory requirements for companies to be aware of at each stage. “With the merging of health-related services and technology comes a number of challenges and legal considerations”, continued Michaela. “Product developers should focus on classification, data protection, consumer protection and IP protection as early as possible in the process so they can ensure the smooth launch of their product.”
The first issue of the Mid-Year Digital Health Review can be accessed here.