On Wednesday, October 6th, Governor Gavin Newsom signed SB 41, the Genetic Information Privacy Act, which expands genetic privacy protections for consumers in California, including those interacting with direct-to-consumer (“DTC”) genetic testing companies. In a recent Covington Digital Health blog post, our colleagues discussed SB 41 and the growing patchwork of state genetic privacy
EDPB Issues New Guidance on the Use of Location Data and Contact Tracing in the Context of the COVID-19 Outbreak
As we anticipated in a previous blog post, on April 22, 2020, the European Data Protection Board (“EDPB”) issued new guidelines on the use of location data and contact tracing apps in the context of the present COVID-19 pandemic.
The EDPB’s new guidelines complement and build on similar guidance previously issued by the Board itself (see here, here and here), and by the European Commission (see our blog post here).
The EDPB’s close scrutiny over the use of mobile data and apps in the context of the ongoing public health crisis is unsurprising, as many EU Member States have launched—or are in the process of launching—contact tracing apps to fight the spread of the virus, and these initiatives are receiving great attention by data privacy authorities and the general public (see our blog post here).
The guidelines aim to clarify the data protection conditions and principles that should be followed when:
- using location data to model the spread of the virus to assess the overall effectiveness of confinement measures; and
- using contact tracing apps, which aim to notify individuals who may have been in close proximity to someone who is infected or confirmed as a carrier of the virus, in order to break the contamination chain as early as possible.
The EDPB stresses that EU data protection rules have been designed to be flexible and, as such, do not stand in the way of an efficient response to the pandemic. However, it notes that governments and private actors should be mindful of a number of considerations when they use data-driven solutions in response to the COVID-19 outbreak.
FDA Issues COVID-19 Policy for Certain Digital Health Solutions
On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19. The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
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Ideation Question #5: Who Will Pay for the Offering?
This is the fifth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: who will pay for the offering?
Reconciling Personalized Nutrition with the GDPR
As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR. Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, available here.
IoT Update: The UK Government’s Response to Centre for Data Ethics and Innovation Consultation
On 20 November 2018, the UK government published its response (the “Response”) to the June 2018 consultation (the “Consultation”) regarding the proposed new Centre for Data Ethics and Innovation (“DEI”). First announced in the UK Chancellor’s Autumn 2017 Budget, the DEI will identify measures needed to strengthen the way data and AI are used and regulated, advising on addressing potential gaps in regulation and outlining best practices in the area. The DEI is described as being the first of its kind globally, and represents an opportunity for the UK to take the lead the debate on how data is regulated.
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Medicare Policies Modified to Support Smart Devices Use for Sharing Glucose Data
The Centers for Medicare & Medicaid Services (CMS) recently announced that Medicare coverage policies would be revised “to support the use of [continuous glucose monitors] in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.” In turn, the agency’s contractors, known as Medicare Administrative Contractors (MACs), modified
U.S. FCC Repeals 2015 Net Neutrality Rules; Impact on Digital Health Solutions Debated
Today, as expected, the U.S. Federal Communications Commission (“FCC”) adopted an order repealing the agency’s 2015 net neutrality rules and changing the legal framework that governs Internet Service Providers (“ISPs”). The vote split along party lines, with the agency’s three Republicans voting in favor and its two Democrats dissenting.
Once today’s order goes into effect,
Obama Administration Releases Final Data Security Policy Principles and Framework for Its Precision Medicine Initiative
Last week I published an article on the Inside Medical Devices Blog, discussing eight data security principles that companies participating in the Precision Medicine Initiative should aim to meet. The Administration’s guidance document additionally recommends a basic framework that organizations collecting, storing, and sharing patient information should adopt as current best practices. The full post
CMS Commits to Investing in Medicaid Technology Systems
On January 11, 2016, Acting Administrator for the Centers for Medicare and Medicaid Services (“CMS”), Andy Slavitt, highlighted investment in Medicaid as one of the “single biggest opportunities in the health care sector.”
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