medical data

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog…

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

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

This week, the Medical Identity Fraud Alliance (“MIFA”) released its 2014 Fifth Annual Study on Medical Identity Theft, finding that in the last year, medical identity theft incidents increased by 21.7% from 2013.  The study is annually conducted to determine the pervasiveness of medical identity theft in the United States, how it affects the lives of victims, and what steps should be taken by consumers, healthcare providers, and governments to reduce the incidence of this crime.  Medical identity theft is defined by the report as occuring “when someone uses an individual’s name and personal identity to fraudulently receive medical services, prescription drugs and/or goods, including attempts to commit fraudulent billing.”  In this study, medical identity theft also is deemed to occur when an individual shares his or her health insurance credentials with others.
Continue Reading Study Shows Increase in Medical Identity Theft

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