The European Commission has actively promoted the importance of mHealth following their 2014 consultation. One of the initiatives to emerge from the Commission has been the Privacy Code of Conduct for mHealth apps. The Code was drafted by a working group set up in January this year and the final draft was published on 7th June and submitted to the Article 29 Working Party for their consideration and approval. If and when it receives the Working Party’s approval it could then be relied upon by app developers wishing to demonstrate a good standard of data protection compliance. The Code is an example of the type of initiative that is increasingly likely to develop under the forthcoming EU General Data Protection Regulation.
Following the launch of its mHealth Developer Portal last October, the HHS Office for Civil Rights has released guidance clarifying how HIPAA applies to mobile health apps. Ensuring that developers understand their legal obligations is critical to protecting consumer privacy and security, especially now that there are more than 165,000 health apps available in the iTunes and Android app stores. A more clear understanding of how the rules apply can also help bring down barriers to innovation.
The HHS Office for Civil Rights has launched an online portal designed to solicit questions from mHealth developers regarding compliance with HIPAA privacy and security requirements. The portal is designed to demystify HIPAA for app developers while providing guidance to regulators about which aspects of HIPAA may require clarification.
In our previous post we outlined the key issues regarding mHealth devices and services from a privacy law perspective. Now, we go further into the details and discuss the scope of the personal data involved, especially relating to sensitive health data. We introduce the relevant statutory requirements in the EU and the legal opinions of the Article 29 Working Party and the European Data Protection Supervisor as well as having a look at the upcoming European General Data Protection Regulation. Against this legal background, one core question we will examine is whether information collected and processed by lifestyle apps and devices must be classified as health data and fall under the strict requirements of European data protection laws.
The mobile Health sector is rapidly developing and revolutionising the healthcare market. More and more consumers share information such as medical and physiological conditions, lifestyles, daily activity and geolocation via all kinds of health-related mobile applications and devices. The growing success of mHealth, however, inevitably casts a spotlight on compliance with privacy protection laws. Data protection agencies and supervisory bodies in the EU recently raised concerns about the collection, processing and use of customers’ data by mHealth apps and mobile devices. This blog introduces the key hot spots involving mHealth and data protection laws, before we dig deeper on other issues in a series of consecutive posts on this blog in the upcoming weeks.
Hogan Lovells partner Marcy Wilder will speak on “Health Policy & Regulatory Environments: A Mobile Perspective” at the 2012 mHealth Summit on December 4. The panel discussion will cover major policies impacting the current and future use of mobile devices in America, specifically addressing the role of mobile devices in accountable care organizations, HIPAA compliance, […]