DTx Featured Can you get your DTx covered by US Public Insurance? 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.
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.
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.
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.
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 Protection Privacy Shield: how its demise impacts digital health Recently, the European Court of Justice overturned the EU-US Privacy Shield. This judgement has significant consequences for digital health companies.
Data Protection Digital therapeutics: A new business model for eHealth 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 Compliance GDPR for US health companies 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?
Data Protection Trust in eHealth: the good, the bad and the ugly The eHealth market is one of the fastest growing in the world. Users want to access the benefits of personalised healthcare, but in doing so, they are entrusting you with their most valuable and personal data. Mess up and you risk losing that trust and killing your market.
MDR The MDR – a step-by-step guide for eHealth The MDR will be enforced from May 2020. To help companies prepare for it, the EU has published a step-by-step implementation plan. Here we explain how the 12 step plan applies to eHealth companies.
GDPR Compliance Digital Health Business guide to Data Protection Officers (DPO) The Data Protection Officer (DPO), is a corporate figure introduced by the General Data Protection Regulation GDPR, the EU's new law on Data Protection and Privacy matters.
Health Data Security Health data and data privacy: storing sensitive data under GDPR Under GDPR law, sensitive data is in a much higher risk category than other types of personal data. Businesses that store sensitive health data should focus on GDPR administrative and technical recuirenments.
Data Protection Is GDPR consent required for the use of anonymous data? Under GDPR, anonymous data is not treated as personal data, therefore no user consent and no particular protection is required. However, it is very difficult to ensure that the data is truly anonymous.
News Frontiers of Health - The Digital Health event in the EU Some time ago we attended the Frontiers Health, the healthcare innovation edition of Frontiers Conferences. Designed to provide a unique platform to learn, exchange and get inspired on the topics of digital disruption and technologies in healthcare.
GDPR Compliance The new EU General Data Protection Regulation (GDPR) General Data Protection Regulation (GDPR) unify the legal framework at EU level and focus on new technologies to establishing the lawful processing of users' data.
Health app compliance Tips healthcare organisations need to know about GDPR Digital Health applications collecting personal and sensitive data must comply with Data Protection Laws. For application developers identifying relevant laws, extracting rules and obligations and implementing them within their applications could be extremely challenging, expensive and risky.
