Health app compliance

Women’s health apps are more than a trend—they’re revolutionising digital health. But here’s the kicker: a deep dive into the top 20 Play Store apps revealed a shocking gap in data privacy, with only one app meeting standards.

With the Access Prescription Digital Therapeutics Act, we may witness a change that promises to transform healthcare delivery with benefits for both digital health companies and millions of American citizens.

France has introduced a fast-track market access pathway for DTx and digital health products, adding to similar schemes in neighboring EU countries Germany (DVG for DiGA) and Belgium.

Many digital health companies, afraid of the costs and timeline of a proper GDPR implementation, opt for a strategy to store personal and sensitive data inside the devices, hoping to circumvent the regulation.

DTx reimbursement policies are fragmented and defined at a national level. Learn how to solve data protection and security compliance challenges to get reimbursed in the EU, UK, and the US.

2020 was the year digital health proved its worth helping respond to the pandemic. So, what challenges and developments will 2021 bring? Here are my predictions.

Recently, the European Court of Justice overturned the EU-US Privacy Shield. This judgement has significant consequences for digital health companies.

Digital therapeutics is the next big thing in digital health. Governments globally are legislating to give access to digital health apps for treatment. As a developer, this offers new ways to monetise your application. But it brings strict requirements for quality, data protection and data security.

GDPR has a huge potential impact on US companies. Since coming into force in May 2018, data protection authorities have dealt with over 200,000 cases, imposing €56 million in fines on companies from all over the world. So, what do you need to know about GDPR compliance?