Join McDermott next Wednesday for a live webinar on the unique considerations in developing and procuring AI solutions for digital health applications from the perspective of various stakeholders. We will discuss the legal issues and strategies surrounding:

  • Research and data mapping essential to the development and validation of AI technologies
  • Protecting and maintaining intellectual property rights in AI solutions
  • Technology development
  • Risk management and mitigation for various contractual arrangements, including contracts with customers, vendors and users

We will also focus on the trends in US law for AI solutions in the digital health space, and present actionable advice that will help you develop an effective strategy for developing and procuring AI solutions for digital health applications.

Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors
Wednesday, June 13, 2018 | 11:00 am CT | 12:00 pm ET
Register Here

 

As Europe’s General Data Protection Regulation (GDPR) takes effect, companies around the world are racing to implement compliance measures. In parallel with the GDPR’s development, China’s new data protection framework has emerged over the past year and is in the final stages of implementing the remaining details. With similar and often overlapping obligations, full compliance with the GDPR and China’s data protection framework presents a significant new challenge for companies with operations in China.

Does the GDPR Apply to Companies in China?

The GDPR applies to the processing of personal data of people who are in the European Union, even for a controller or processor in China, where the processing of the data is related to:

  • The offering of goods or services to the data subjects in the European Union, regardless of whether a payment is required; or
  • The monitoring of people’s behavior in the European Union.

As a result, even if a Chinese company does not have any formal establishments in the European Union, the GDPR will nonetheless apply if it is conducting either of these two types of activities.

What Are the Requirements for Companies in China Subject to the GDPR?

The GDPR primarily focuses on two categories of entities: “controllers” and “processors.” These two types are similar to concepts in the Chinese rules.  “Controllers” are entities that, alone or jointly with others, determine the purposes and means of the processing of personal data. “Processors” are entities that carry out the processing of personal data on behalf of the controllers.

Key requirements for most controllers under the GDPR: Continue Reading The GDPR’s Effects in China: Comparison with Local Rules and Considerations for Implementation

Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12 months and in almost all of the $1 million-plus settlements during that time period. Significant confusion remains across the health care industry as to what actually constitutes a compliant risk analysis for purposes of the HIPAA Security Rule. On April 30, 2018 OCR issued guidance discussing the differences between a HIPAA Security Rule risk analysis and a HIPAA compliance “gap analysis.” Drawing from our experience reviewing clients’ historical risk analysis documents, helping clients to navigate OCR investigations and negotiating several recent HIPAA settlements with OCR, we elaborate on what constitutes a compliant HIPAA Security Rule risk analysis, discuss common risk analysis misunderstandings and pitfalls, and encourage covered entities and business associates to consider whether to conduct these reviews under attorney-client privilege.

Continue Reading.

Earlier this month, more than 45,000 attendees descended on Las Vegas, NV, for the nation’s largest annual health care technology conference: the 2018 HIMSS Conference & Exhibition (HIMSS18). Conversations and educational sessions covered a wide range of health tech topics, with thought leaders, solutions developers, health system executives, patient advocates and care providers coming together to discuss the myriad obstacles and opportunities facing the health care technology industry today.

On Tuesday March 6, during the HIMSS conference, McDermott Will & Emery along with our friends at Capstone Headwaters convened a panel discussion on “Financing High-Growth Healthcare IT Companies, which I had the pleasure of moderating. The seasoned mix of health care finance and private equity professionals discussed the various types and sources of capital available to fuel high-growth health IT organizations and how to choose the right mix of capital to support a company’s growth needs. We also reviewed the legal and regulatory implications for investments in health care IT companies, and discussed considerations for optimal positioning in a value-based care environment.  Continue Reading Financing High-Growth Health IT Companies: McDermott and Capstone’s Panel Recap from HIMSS 18

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.

Continue reading.

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.

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