Archives: Uncategorized

Subscribe to Uncategorized RSS Feed

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 … Continue Reading

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 … Continue Reading

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.… Continue Reading

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 … Continue Reading

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 … Continue Reading

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, … Continue Reading

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 can … Continue Reading

ONC Releases 2016 Interoperability Standards Advisory

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

CMS Proposes Changes to Recertification of Electronic Health Record Technology

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

Agency for Healthcare Research and Quality Releases Draft Report Calling for Further Research into Telehealth

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

HHS Launches Portal Seeking Questions from Mobile Health Application Developers

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

E-Prescribing of Controlled Substances Now Permissible in All States.

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

The Proposed Medicare Telehealth Parity Act of 2015 Would Expand Medicare Reimbursement for Telehealth Services

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 Independence at Home Demonstration Project Completes its First Year and Saves over $25 Million

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

21st Century Cures Act with EHR and Telehealth Provisions Passes Through Committee with Flying Colors

* 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

New Efforts to Combat Health Information Blocking

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

FTC Staff Submit Comments On ONC’s Draft Shared Nationwide Interoperability Roadmap

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

Continuing Developments on Telemedicine in the U.S. Senate

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

CMS Releases Proposed Rules Modifying Stage 2 of EHR’s Meaningful Use Requirements

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

Study Finds That Majority of Health-Related Websites Share Personal Information With Third-Parties

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

President Obama Announces Precision Medicine Initiative, Presses for Cybersecurity Legislation

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