Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA.

Visit www.

This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services Secretary Eric D. Hargan made a formal declaration under Section 319 of the Public Health Service Act, making available an exception to the

The opioid epidemic is making the United States acutely aware of the horrors of substance abuse disorders and the limited means of treating the individuals suffering from addiction. Rural America is among the places hit hardest by opioid addiction while also having limited access to mental and behavioral health providers.

Telemedicine offers a viable solution

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing

As the Federal Communications Commission repeals the Open Internet Order—more commonly known as the net-neutrality rules—health care consumers and providers have been left wondering how this change will affect their ability to receive and deliver health care using digital health tools. In this On the Subject, we outline how changes in internet access will

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program Final Rule published on November 15, 2017 (the Final Rule). Among many other developments, the Final Rule expands allowable telehealth reimbursement under the calendar year (CY) 2018 Physician Fee Schedule, List of Medicare Telehealth Services (list) and permits virtual sessions in certain circumstances under the Medicare Diabetes Prevention Program Expanded Model (MDPP, or the Program). The regulations are effective January 1, 2018.

“New” and “Add-On” Telehealth Services Slated for Reimbursement

CMS evaluates requests for the addition of telehealth services on the basis of two categories: (1) services that are similar to services already on the list and (2) services that are not similar to services already on the list. An evaluation of a category (2) service requires CMS to assess, based on the submission of evidence, whether the use of a telecommunications system to furnish the service “produces demonstrated clinical benefit to the patient.”
Continue Reading

President Trump declared the opioid addiction epidemic a public health emergency yesterday. The White House made it clear that this declaration would allow officials to remove barriers to the prescribing of controlled substances via telemedicine, which would permit DEA registered providers to prescribe anti-addiction medications, such as Naloxone, to patients in need without first performing

On September 29, the Federal Trade Commission (FTC) formally announced a December 12th workshop on informational injury—the injury a consumer suffers when information about them is misused. The workshop will address questions such as, how to characterize and measure such injury and what factors businesses and consumers should consider the benefits and risks of collecting, using and providing personal information so as to gain further perspective for how the FTC should apply its legal framework for privacy and security enforcement under 15 USC § 45 (Section 5). In her September 19th remarks to the Federal Communications Bar Association, Commissioner Maureen Ohlhausen, the Acting Chairman of the FTC, metaphorically characterized the workshop’s purpose as providing the next brushstrokes on the unfinished enforcement landscape the FTC is painting on its legal framework canvas. The full list of specific questions to be addressed may be accessed here.

Background. The FTC views itself as the primary US enforcer of data privacy and security, a role it recently assumed. While the FTC’s enforcement against practices causing informational injury through administrative proceedings goes back as far as 2002, its ability to pursue corporate liability for data security and privacy practices under its Section 5 “unfair or deceptive trade practices” jurisdiction was only ratified in 2015 by the US Court of Appeals for the Third Circuit in FTC v. Wyndham Worldwide Corporation. The FTC has actively invoked its enforcement authority but, in doing so, has been selective in determining which consumer informational injuries to pursue by questioning the strength of evidence connecting problematic practices with the injury, examining the magnitude of the injury and inquiring as to whether the injury is imminent or has been realized.
Continue Reading

On July 31, 2017, President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that he declare the opioid epidemic a national emergency. In August 2017 and again on October 16, 2017, the president indicated he would declare the opioid crisis a national emergency. While it is apparent that the nation is suffering a drug overdose and opioid-specific crisis, the question remains as to what effect such a declaration would have on combatting the crisis.

The president’s powers to declare a national emergency arise from the Stafford Act, and once a national emergency is declared, it enables 1) access to US Department of Homeland Security ‒ Federal Emergency Management Agency (FEMA) funding, with states able to request grants for the specific purposes of treating opioid addiction; 2) the ability to re-appropriate federal agency workers, such as those employed by the agencies under the US Department of Health and Human Services (HHS) umbrella, to specifically research and treat opioid addiction; and 3) waiver of federal Medicaid regulations to provide additional aid to beneficiaries, ensuring sufficient health care items and services are available to meet the needs of beneficiaries. Such a declaration would undoubtedly open up both federal and state governments to formulate a comprehensive, unified strategy to combat the opioid epidemic sweeping the nation.
Continue Reading

New cybersecurity regulations issued by the NYDFS define the nonpublic information they regulate in exceptionally broad terms. This expanded definition of Nonpublic Information will create major challenges for regulated companies and their third-party service providers that will likely ripple through other ancillary industries.

Continue Reading.