Join us on Tuesday, April 18, 2017 from 12:00–1:00 pm ET for a webinar that will address, among others, the following issues:

  • Overview of EU security rules
  • Securing the IoT
  • Product liability and other potential claims
  • Health care reimbursement and fraud issues
  • Cyber liability insurance

Click here to register.

Speakers include:

1 hour CA and NY MCLE credit is pending. CLE credit for other jurisdictions is also pending.

The Federal Communications Commission’s (FCC) Connect2Health Task Force is launching a new mapping tool that it states will support efforts to chart the intersection of broadband and healthcare. The FCC intends for the tool to support more efficient, data-driven decision making by enabling users to ask and answer questions about broadband and health at the county and census block levels. For example, a pilot map of Virginia released by the Task Force in April 2015 overlays the state with data sets such as population distribution, physician distribution, county population per primary care provider, online access to health information, most-common download speed, and obesity prevalence. By offering a nationwide tool, the FCC expects to assist policymakers, industry leaders, health technology innovators, consumer advocates, clinicians, rural health organizations, county and city health officials, and others to leverage technology for addressing health needs. For more information on the launch of the new mapping tool, the FCC’s public notice is available here.

On May 18, 2016, the FCC’s Connect2Health Task Force and the University of Houston Law Center’s Health Law & Policy Institute will hold a conference to highlight how broadband-enabled health technologies can improve access to mental health care and to discuss associated policy issues.  The entire conference will be viewable through a free webcast at  Panels throughout the day (a full list of which can be found here) will include discussions of the challenges faced along the spectrum of care and how connected solutions can help address those needs, approaches for improving health outcomes through care coordination, personalized care and big data analytics from the start-up and incubator perspectives, and the legal and regulatory landscape for connected mental health technologies, as well as policy solutions to improve access and outcomes.  The day will also feature a virtual demonstration of how the Internet is being leveraged to provide virtual care between clinical encounters and to promote self-management.

Companies interested in the rapidly growing world of the Internet of Things (IoT) may want to participate in the recent Request for Comment (RFC) by the National Telecommunications and Information Administration (NTIA), an agency of the US Department of Commerce.  NTIA seeks input from all interested stakeholders on a range of issues surrounding IoT, including, but not limited to, technological, infrastructure, economic, international, and policy issues.  NTIA also seeks comments on the definition of IoT, described as “the broad umbrella term that seeks to describe the connection of physical objects, infrastructure, and environments to various identifiers, sensors, networks, and/or computing capability.  In practice, it also encompasses the applications and analytic capabilities driven by getting data from, and sending instructions to, newly-digitized devices and components.”

For a more detailed discussion of NTIA’s RFC, read Arnold & Porter’s advisory, NTIA Seeks Comment on Policy Issues Related to the Internet of Things or visit the SellerBeware blog and read the latest post.

The FCC’s Office of Engineering and Technology (“OET”) has provided until February 12, 2016 for comments (and February 29, 2016 for replies) on Sensifree, Inc.’s (“Sensifree”) request for waiver of the Commission’s rules to obtain an FCC equipment authorization for a “body-worn ultra-wideband (‘UWB‘) heart rate monitoring device.”  Without the equipment authorization, it is unlawful for Sensifree to “manufacture, import, sell, offer for sale, or ship” the device in or to the United States.

According to Sensifree’s filing, its heart rate sensor can electromagnetically detect changes in the user’s artery diameter caused by the repetitive cycle in blood pressure inside the artery.  The FCC’s Public Notice notes that the “device’s transmitter frequency-hops over a range of frequencies depending on where it is placed on the body” and that “a wrist-worn device would operate between 5 and 10 GHz; an arm-worn device would operate between 3.1 and 7 GHz; and a chest-worn device would operate between 3.1 and 4.1 GHz.”

Sensifree’s monitor does not quite meet the FCC’s definition of a UWB transmitter in 47 C.F.R. § 15.503(d) because the instantaneous bandwidth of each individual frequency hop is less than the minimum 500 megahertz required by the FCC’s rule.  Sensifree, nevertheless, seeks a waiver of this rule to obtain permission to market and sell its device in the United States.

Parties interested in commenting on this waiver request can file online through the FCC’s Electronic Comment Filing System.

Stakeholders have until January 14, 2016, to offer comments on a series of reforms to the Rural Health Care (RHC) program proposed in a Petition for Rulemaking filed with the Federal Communications Commission (FCC or Commission) in early December by a group of rural healthcare providers and the Schools, Health & Libraries Broadband Coalition.  The petitioners claim their proposals will ameliorate health and technology-access disparities between rural and non-rural Americans “by supporting universal deployment of advanced telecommunications and information services to health care providers.”

First, the petitioners argue requirements of the RHC’s Healthcare Connect Fund (HCF) unduly discourage participation in the program.  In particular, they claim the 35 percent of project costs required from recipients of support is too onorous and should be reduced to 15 percent.  Especially since administrative costs are not eligible for support, the size of the match makes it difficult to form consortia of unaffiliated healthcare providers – even when they are the most efficient vehicle for improving rural healthcare delivery through connectivity.

Second, the petitioners seek greater funding for the RHC, asserting that the current $400 million annual funding cap was not based on an accurate record and “may grossly undercount” the number of potentially eligible healthcare providers.  Pointing to a number of alleged flaws in the Commission’s methodology for setting the funding cap, the petitioners ask the Commission to seek public comment about (1) the number of potentially eligible providers and (2) the availability of fiber-optic communications connections to potentially eligible providers as well.

Continue Reading FCC Seeks Comment on Major Reforms to the Rural Health Care Program

The Federal Communications Commission (FCC) recently announced that it had selected Enterprise Wireless Alliance (EWA) as the frequency coordinator for Medical Body Area Network (MBAN) operations in the 2360-2390 MHz band. The selection of EWA clears the way for the deployment of MBAN technology, which will allow for the short-range wireless networking of multiple body transmitters used for gathering patient information or for performing diagnostic or therapeutic functions.  The United States is the first country to allocate wireless spectrum for MBANs.

As the frequency coordinator, EWA will ensure interference-free sharing of the band. In particular, EWA will be responsible for recording and managing the deployment of MBAN systems in healthcare facilities, as well ensuring that MBAN devices do not interfere with aircraft testing facilities authorized to operate in the same frequencies.  EWA will maintain a database of MBAN transmitter locations and operational parameters and is developing an online system for MBAN registration.

Continue Reading FCC Announces Medical Body Area Network (MBAN) Frequency Coordinator, Clearing the Path for Use of MBAN Equipment

Welcome to your first edition of the Digital Health Download Blog. Our mission is to provide substantive cross-functional analysis of noteworthy digital health industry developments. For decades, Arnold & Porter LLP’s FDA and Healthcare practice has been a leader in helping pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, respond to complex regulatory and compliance challenges. The convergence of software, digital, mobile and medical technologies is changing the way consumers and healthcare providers (HCPs) manage health and treat disease. These products and solutions provide greater flexibility, connectivity, and information to patients, providers and government and private payors. While they present numerous opportunities to revolutionize healthcare, these technologies also present a number of legal and regulatory challenges that encompass issues such as litigation, privacy and cybersecurity, telecommunications, mergers and acquisitions, intellectual property, healthcare compliance and corporate governance. We have a long tradition of leveraging the knowledge, experience and know-how of attorneys across various disciplines and practice areas to maximize efficiencies and provide practical advice and assistance to our clients. Our editorial team and contributors will strive to provide news, information and thought-provoking analysis that reflect our cross-functional approach and diverse perspectives.