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 … Continue Reading
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 … Continue Reading
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?… Continue Reading
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.… Continue Reading
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 … Continue Reading
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 … Continue Reading
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, … Continue Reading
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 can … Continue Reading
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.” … Continue Reading
On December 22, 2015, the ONC released the 2016 Interoperability Standards Advisory, which is meant to serve as a “single resource for those looking for federally recognized, national interoperability standards and guidance,” according to ONC’s Director of the Office of Standards and Technology Steven Posnack, MS, MHS, and Director of HIT Infrastructure and Innovation Division … Continue Reading
Last week, the Centers for Medicare and Medicaid Services (CMS) published a request for information (RFI) seeking public comment regarding areas of certification and testing of health IT as part of the Electronic Health Records (EHR) meaningful use program. Beginning in 2018, participants in the Stage 3 Meaningful Use EHR incentive program must electronically report … Continue Reading
The Agency for Healthcare Research and Quality has released a draft report conducting a literature review of studies researching the effectiveness of the current telehealth system. The report was initially requested by Senators Bill Nelson (D-FL) and John Thune (R-SD) to examine the value of telehealth and remote patient monitoring, with a focus on expanding … Continue Reading
A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers. The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications. To read the post, click here.… Continue Reading
The state of Missouri has promulgated regulations effective July 30, 2015 that formally authorize electronic prescribing of controlled substances in Missouri. With these new regulations, Missouri becomes the final state to allow electronic prescribing of controlled substances. Although the Drug Enforcement Administration implemented changes in 2010 to permit electronic prescribing of such drugs, some states, … Continue Reading
Although telemedicine has made many technological advancements in the past decade, it still faces several legal and financial barriers to widespread use and acceptance. Chief among these are poor reimbursement policies; according to the American Telemedicine Association, 29 states earned an “F” for coverage and reimbursement standards. States have attempted to rectify some of these … Continue Reading
The Centers for Medicaid and Medicare Services (CMS) implemented the Independence at Home Demonstration program in January 2012. The Demonstration is testing whether home-based care can reduce the need for hospitalization, improve patient and caregiver satisfaction, and lead to better health and lower costs to Medicare. The Demonstration is part of the new framework established … Continue Reading
* Jack Lund is a summer associate and student at the University of Virginia School of Law The “21st Century Cures Act” (Cures) cleared its first major hurdle last month when the House Energy and Commerce Committee voted unanimously in favor of the legislation. Among other things, Cures helps to modernize Medicare by … Continue Reading
A recent report by the Office of the National Coordinator for Health Information Technology (ONC) found that some health care entities are purposefully hindering the exchange of electronic health information (referred to as “blocking”) for reasons driven by economic and market incentives. Although the federal government has thus far invested $28 billion to facilitate the … Continue Reading
The Federal Trade Commission’s (“FTC”) Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection, and Bureau of Economics recently submitted comments on the Office of the National Coordinator for Health Information Technology (ONC’s) draft Shared Nationwide Interoperability Roadmap (“Roadmap”). As discussed in previous posts, this Roadmap sets forth a ten year plan to … Continue Reading
Last week, the Senate Subcommittee on Communications, Technology, Innovation, and the Internet held a hearing on “Advancing Telehealth through Connectivity.” The hearing explored the need to expand telehealth nationwide, with a particular focus on rural areas. Several experts lauded the benefits of telehealth, including helping to lower health care costs and improve patient outcomes. However, these … Continue Reading
On April 10th, CMS issued a new proposed rule modifying Stage 2 requirements for meaningful use under the Electronic Health Record (EHR) Incentive program. According to CMS, the rule is “intended to be responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015.” The newly proposed modifications are also … Continue Reading
A study published in the March 2015 issue of Communications of the ACM (Association for Computing Machinery) revealed that 91% of health-related websites initiated some type of HTTP request (HTTP is a request/response protocol, by which, for example, a computer sends a request for a file and the web server sends back a response) to … Continue Reading
This year’s State of the Union address included little explicit discussion of health IT, but did highlight two areas that could have significant implications for health IT: the President announced a new “Precision Medicine Initiative” and also urged Congress to pass legislation to combat cyber attacks and prevent identity theft. While the address was scant … Continue Reading
