On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth.

Expanded Access to Telehealth Stroke Services

The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural areas, meaning distant site providers delivering telestroke services could receive a professional fee for delivering the consultation to patients located anywhere in the United States, provided that the other Medicare telehealth coverage requirements are satisfied (e.g., type of provider, type of technology). Continue Reading Bipartisan Budget Act of 2018 Includes Significant Changes in Medicare, Other Federal Health Programs

The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data (Personal Data) about individuals in the European Union (EU) single market countries, and potentially affects the clinical and other scientific research activities of academic medical centers and other research organizations in the United States.

This On the Subject includes frequently asked questions that discuss the extent to which United States research organizations must comply with GDPR when conducting research. Future coverage will address the impact of GDPR on other aspects of the United States health care sector.

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Enforceable in all EU member states on 25 May 2018, the General Data Privacy Regulation will require action by organisations both inside and outside the European Union to ensure compliance with this far-reaching privacy legal framework. Compliance is even more urgent given that the GDPR provides for large penalties in cases of infringement. As some entities are not yet aware of the extent to which GDPR may be applicable to them, the GDPR expressly applies to organisations established outside the European Union that offer paid or free goods or services to EU data subjects or monitor EU data subjects’ behaviour.

Within this article, we review steps for a risk based, prioritization approach to GDPR compliance and how companies can adjust their policies and practices on a pragmatic basis to help ensure compliance.

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On January 30, Attorney General Jeff Sessions announced a surge of Drug Enforcement Administration (DEA) agents and investigators over the coming month and a half, focused on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of opioid drugs. The DEA will examine distribution and inventory data reported to the DEA by prescription drug manufacturers and distributors for “patterns” and “outliers” for further investigation.

Read the full On the Subject.

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.

What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018.  Continue Reading On the Digital Health Frontier: Developments Driving Industry Change in 2018

Stephen Bernstein, global chair of McDermott’s Health Industry Advisory Practice Group, sat down with This Week in Health Innovation at the J.P. Morgan Healthcare Conference in San Francisco.

Stephen and Dr. Andre Berger, CEO of National ACO, discussed the role of advancing technologies in enhancing collaboration between key players in digital health—including doctors, heath plans, investors, and consumers and patients—and how digital health is necessary for improving care delivery and managing costs.

Listen to the full podcast.

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 the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.

We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.

Read the full Special Report.

The proliferation of digital health devices and solutions is at hand. Demand exists around every corner with applications ranging from personal wellness to remote patient monitoring. They are being offered by industry stalwarts and upstarts alike.  Collaborations amongst tech companies, academics, big data providers, entrepreneurs and traditional healthcare players—all of whom bring something valuable to the table and all of whom want to be involved in delivering solutions that can help predict, prevent or more effectively respond to disease—are catalyzing digital health product and service development.  These new relationships are bringing the power of multiple competencies and game-changing perspectives to today’s health care challenges. They have the potential to revolutionize the way we approach health care delivery.  The question is: do these players really know what it will take to work together successfully and, if so, will they be able to get digital health solutions over the finish line?

Listen to McDermott’s Digital Health thought leaders share their perspectives on the proliferation of digital devices and what it means to the marketplace today.

 

Blockchain is rapidly becoming the focus of conversations regarding health care disruption, and for good reason. What started out as a means for cryptocurrency is now making waves in a variety of industries, set to revolutionize how data is stored and shared.

The inability to easily and securely store and share data has long been a burden on the health system. Blockchain poses a solution to that through encryption and highly advanced technological assets which open the doors to health care innovation. Today we see blockchain being used with electronic health records (EHRs) so that a patient’s medical history is easily accessible to him/her, as well as his/her doctors, insurance providers, etc. It’s also providing the “how” in implementing value-based payment agreements, which link payment to performance of a drug or medical device. Blockchain is currently being used both in the private and public sectors, including the FDA and the CDC. While the full potential of this new technology is not yet known, the industry seems eager to find out.

Ahead of this year’s J.P. Morgan Healthcare Conference, we sat down with Lee Schneider, our top blockchain thought leader, to talk specifically about how this new technology is revolutionizing (or has the potential to revolutionize) the health care space. Continue Reading Blockchain: Health Care’s Next Great Disruptor?

In the final days of 2017, the vice chairman of the Standing Committee of China’s National People’s Congress (NPC) submitted a report to the Standing Committee of the NPC detailing the Network Security Law enforcement inspection project that began earlier in the year. This inspection had focused on five key points under the government’s overall data protection strategy:

  • Legal education
  • Supporting laws and regulations
  • Protection of critical information infrastructures and the application of graded protection for network security
  • Illegal network information
  • Personal information protections

Continue Reading New Chinese Government Report Highlights Recent Data Protection Enforcement and Attitudes