mobile health

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government…
Continue Reading Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an undertaking committing to changes to ensure it is acting in line with the UK Data Protection Act.

On September 30,  2015, the Royal Free entered into an agreement with Google UK Limited (an affiliate of DeepMind) under which DeepMind would process approximately 1.6 million partial patient records, containing identifiable information on persons who had presented for treatment in the previous five years together with data from the Royal Free’s existing electronic records system.  On November 18, 2015, DeepMind began processing patient records for clinical safety testing of a newly-developed platform to monitor and detect acute kidney injury, formalized into a mobile app called ‘Streams’.
Continue Reading ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

The EU-U.S. Privacy Shield’s recent introduction has created an efficient mechanism to ensure that trans-Atlantic personal data flows are lawful.  With that in place, attention is now turning back to restrictions within the EU, particularly around hosting data in cloud computing services.

European healthcare is particularly affected by such restrictions.  This has motivated a significant group of organizations and policymakers to come together and launch a collective “call to action” to European policymakers, urging greater support and reforms to enable broader use of cloud computing in healthcare.  The Call to Action was previewed at eHealth Week 2016 in June.
Continue Reading EU Organizations Call for More Support for Cloud Computing in Healthcare

The Article 29 Data Protection Working Party (Working Party), an independent EU advisory body on data protection and privacy, responded to a request from the European Commission made in the framework of the Commission’s  mHealth initiative to clarify the definition of data concerning health in relation to lifestyle and wellbeing apps.  (See more here, and here for our blog post on the European Commission’s Summary Report of the mHealth consultation.)

In its latest paper on health data in apps and devices, the Working Party supports a broad definition of health data, distinguishing the following three categories of health data:

  1. The data are inherently/clearly medical data, especially those generated in a professional, medical context.
  2. The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person.
  3. Conclusions are drawn about a person’s health status or health risk (irrespective of whether these conclusions are accurate, legitimate or otherwise adequate or not).
    Continue Reading Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices

The European Commission has finally published its summary of 211 responses to its mobile health (“mHealth”) consultation.  The summary and original responses to the consultation have been made available on the Commission’s website at https://ec.europa.eu/digital-agenda/en/news/summary-report-public-consultation-green-paper-mobile-health

The consultation covered a broad range of important issues for mHealth, including legal frameworks, privacy and data protection, patient safety, mHealth’s role in healthcare systems, equal access, interoperability, funding and reimbursement, liability, research & innovation, international cooperation, and market access issues, particularly for web entrepreneurs.
Continue Reading Summary Report of European Commission’s mHealth Consultation Published