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A Net-Neutral Decision for Health Care? What Providers Can Expect in the Wake of Net Neutrality Repeal
By McDermott Will & Emery and Lisa Mazur on Dec 26, 2017
Posted In Big Data, Cybersecurity, Data Privacy, Telehealth
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 affect...
By McDermott Will & Emery and Lisa Mazur on Dec 7, 2017
Posted In Big Data, Mobile Apps, Telehealth
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...
Declaration of Public Health Emergency Changes Remote Prescribing Requirements but Creates Many Questions Waiting to Be Answered
By McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. on Oct 26, 2017
Posted In General Interest, Telehealth
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...
Upcoming FTC Workshop on Informational Harm | Next Brushstrokes on the FTC’s Consumer Privacy and Security Enforcement Canvas
By McDermott Will & Emery and Bernadette M. Broccolo on Oct 25, 2017
Posted In Consumer Protection, Cybersecurity, Data Privacy, Telehealth
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,...
The Opioid Crisis: Declaring a National Emergency and the Effect on Remote Prescribing through Telemedicine
By McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. on Oct 20, 2017
Posted In Telehealth
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...
By McDermott Will & Emery, Michael G. Morgan, Mark E. Schreiber and Scott Weinstein on Sep 20, 2017
Posted In Cybersecurity, Data Privacy
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.
By McDermott Will & Emery and Dale C. Van Demark on Sep 15, 2017
Posted In Advertising & Marketing, Cybersecurity, Data Privacy, General Interest, Telehealth
Although the incorporation of technology into human endeavours—commercial, political and personal—is a normal component of technological innovation, the advent of artificial intelligence technology is producing significant challenges we have not felt or understood with earlier innovations. For many years, for example, there has been speculation, research and public debate about the impact of the internet,...
By McDermott Will & Emery and Lisa Mazur on Aug 23, 2017
Posted In Consumer Protection, Data Privacy
The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the experiences of 17 individuals and processes of 50 health systems, with commentary from four medical record fulfillment administrators, to determine how the medical...
FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program
By McDermott Will & Emery and Vernessa T. Pollard on Aug 7, 2017
Posted In Data Privacy, General Interest, Telehealth
Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation...
By McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. on Jun 27, 2017
Posted In General Interest, Telehealth
On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29,...