DTx DTx: the PECAN French reimbursement scheme is approved. 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.
Health Data Security 3 ways to use sensitive data for product improvement in B2B digital health In this blog article, we will go through this topic from the POV of a digital health startup and try to give you a better understanding of when you should ask for consent and why.
GDPR Basics Is it a good idea to have an internal DPO? If you are running a project dealing with personal or sensitive, you may already have heard at least once those three letters: DPO.
GDPR Compliance What does the ban on ChatGPT mean for AI startups in Europe? Italy’s data protection authority has ordered OpenAI to stop processing people’s data locally with immediate effect. The Italy DPA claims that ChatGPT is breaching the GDPR due to unlawful data processing.
Anonymization Is data anonymous when we remove the personal identifiers? Sharing data for the purposes of data analysis can have huge benefits. The question is how to do so in a way that protects privacy.
GDPR Compliance Do we avoid GDPR when we leave the data on the device? 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.
Compliance Can you use AWS/Azure/Google Cloud in digital health in the EU in 2023? After the invalidation of the previous adequacy decision on the EU-US Privacy Shield, the US is still considered TODAY a Third country without an Adequacy Decision according to GDPR.
Compliance “My users put personal data into my app, even though I tell them not to” What happens when a user puts personal data in a free text field even though we tell them not to? How do we deal with this case?
Artificial Intelligence ChatGPT: can (should) it handle sensitive data? Although the tool can boost AI innovation, it is crucial to keep in mind that there are still some “grey areas” on the data protection and privacy side. We will focus our assessment on the GDPR.
Artificial Intelligence Artificial Intelligence Act: How can Digital Health startups get ready The EU is preparing the world’s first proposal for regulating AI. This new regulation will likely become a global gold standard and a blueprint for other nations outside the EU.
Artificial Intelligence How to prepare yourself for the Artificial Intelligence wave in Digital Health - Pt.1 Privacy can limit the amount of available data in healthcare. Sometimes, It seems like it is not possible to benefit from the AI advantages while keeping intact and safe patients’ data.
GDPR Basics It’s never too late to tackle GDPR. 6 steps for innovative companies to remediate compliance. It’s never too late to tackle GDPR and transform it into a unique opportunity to gain trust, build solid relationships with your customers and partners and grow better.
EU-project Long COVID: identify the mechanisms behind the syndrome. The EU project will conduct research dedicated to identifying and understanding these mechanisms and will simultaneously develop suitable treatment methods for patients based on the findings.
Compliance GDPR: what fast-growing B2B startups got right to close A-deals How can you stand apart? Startups need to get GDPR done right in order to achieve their business goals and start selling.
GDPR Compliance 5 ways to sell better with data privacy and security compliance Providing proof of your expertise and compliance readiness will strengthen your reputation and position your brand as a trustworthy partner. If you don’t have your compliance set up right… Well, you may have some trouble closing deals and meeting investors’ expectations!
Data Breaches Security problems found in two DiGAs. What you can do to avoid them. The hacker collective discovered massive security gaps in two approved DIGAs. Learn how to avoid security issues in your digital health app.
DTx Featured Digital Therapeutics (DTx): how to get reimbursed in the EU, UK and the US. An overview of the existing regulatory frameworks. 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.
Case Study Featured From zero to market: how to build and launch a compliant digital health app in 1 year Compliance-by-design is a key factor when developing a digital health solution. We interviewed Ravid Israel, founder and CEO of Embie. A case study to understand the importance of GDPR and privacy compliance for digital health projects.
Data Protection Beyond Google Analytics: What the Austrian DPA decision means to you The Austrian DPA declared that websites using Google Analytics are breaching GDPR due to personal data transfers to the US company. The impacts go well beyond Google Analytics though. Find out what you can do to address this.
Data Protection Securing your business: the Chino.io DPOaaS service A data protection officer is your on-call expert for GDPR. If you handle lots of sensitive data, you need one. Outsource your DPO needs to us
GDPR Basics GDPR basics: DPOs explained for digital health companies Many digital health companies struggle to understand GDPR. In this series, we explain some important concepts and give examples. We start with the role of data protection officer.
DVG DVG and US cloud providers: the latest updates The ECJ Schrems II judgement had a big impact on DiGA developers. Since then, they have been seeking clarity on exactly what is and isn’t allowed. Here, we shed some light on the latest updates from both BfArM and the EDPB.
GDPR Compliance Brexit, data transfers and the implications for digital health Brexit is finally done and the UK is no longer bound to the EU. However, loose ends remain. One is the status of GDPR after the end of June. Read on to find out more.
Health app compliance 2021: predictions for the digital health sector 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.
Data Breaches 3 ways digital health apps can avoid scandal October saw a worrying new form of crime targeting digital health. We are only now starting to see the implications. Here, I explain how you can help protect your users.