The FTC released this week a web-based tool to assist mobile app developers in determining which federal privacy laws apply to their mobile health applications. The tool asks developers a series of ten targeted questions that help a user determine whether HIPAA, FTC, and/or FDA rules and regulations might apply.
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.
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.
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, […]