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Health app compliance

A collection of articles regarding Health Applications (mHealth, eHealth) and how to achieve compliance with the most known Data Protection laws.

2021: predictions for the digital health sector
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.

  • Jovan Stevovic
    Jovan Stevovic
4 min read
Privacy Shield: how its demise impacts digital health
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.

  • Nicola Brunello
    Nicola Brunello
  • Toby Moncaster
    Toby Moncaster
3 min read
Digital therapeutics: A new business model for eHealth
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.

  • Jovan Stevovic
    Jovan Stevovic
3 min read
GDPR for US health companies
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?

  • Ruta Naujokaite
    Ruta Naujokaite
3 min read
Trust in eHealth: the good, the bad and the ugly
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.

  • Toby Moncaster
    Toby Moncaster
3 min read
The MDR – a step-by-step guide for eHealth
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.

  • Toby Moncaster
    Toby Moncaster
3 min read
Digital Health Business guide to Data Protection Officers (DPO)
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.

  • Jovan Stevovic
    Jovan Stevovic
2 min read
Health data and data privacy: storing sensitive data under GDPR
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.

  • Toby Moncaster
    Toby Moncaster
3 min read
Is GDPR consent required for the use of anonymous data?
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.

  • Ruta Naujokaite
    Ruta Naujokaite
3 min read
Frontiers of Health - The Digital Health event in the EU
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.

  • Jovan Stevovic
    Jovan Stevovic
1 min read
The new EU General Data Protection Regulation (GDPR)
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.

  • Jovan Stevovic
    Jovan Stevovic
1 min read
Tips healthcare organisations need to know about GDPR
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.

  • Stefano Tranquillini
    Stefano Tranquillini
3 min read
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