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Cybersecurity

The General Data Protection Regulation: Key Requirements and Compliance Steps for 2018

by Jared T. Nelson, Leon C.G. Liu, Michael G. Morgan, Mark E. Schreiber, Paul McGrath, Romain Perray, Sabine Naugès, Dr. Wolfgang Freiherr Raitz von Frentz and McDermott Will & Emery | Feb 6, 2018 | Big Data, Consumer Protection, Cybersecurity, Data Privacy

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.

On the Digital Health Frontier: Developments Driving Industry Change in 2018

by Jiayan Chen and Lisa Mazur | Jan 25, 2018 | Big Data, Consumer Protection, Cybersecurity, Data breach, Data Privacy, Mobile Apps, Telehealth

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. (more…)

Podcast | Stephen Bernstein Joins ‘This Week in Health Innovation’ to Discuss Future of Digital Health

by Stephen W. Bernstein | Jan 24, 2018 | Big Data, Consumer Protection, Cybersecurity, Data Privacy, General Interest, Telehealth

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.

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark, Jennifer S. Geetter, Jiayan Chen, Lisa Mazur, Michael W. Ryan, Scott Weinstein and Vernessa T. Pollard | Jan 12, 2018 | Advertising & Marketing, Big Data, Cloud, Consumer Protection, Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, Mobile Apps, Telehealth

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: Health Care’s Next Great Disruptor?

by Lee A. Schneider | Jan 5, 2018 | Big Data, Consumer Protection, Cybersecurity, Data Privacy, Ecommerce, General Interest, Telehealth

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. (more…)

New Chinese Government Report Highlights Recent Data Protection Enforcement and Attitudes

by Jared T. Nelson and Shi Yuhang | Jan 4, 2018 | Advertising & Marketing, Consumer Protection, Cybersecurity, Data Privacy

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

(more…)

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 | Dec 26, 2017 | 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 digital health and what the regulatory landscape will look like in the coming months and years.

Read the full article.

Transferring Data from China: Who Must First Pass a Pre-Export Security Assessment?

by Jared T. Nelson and Leo Yang | Dec 22, 2017 | Big Data, Consumer Protection, Cybersecurity, Data Privacy

China’s new data protection framework clearly creates a requirement for local storage and conducting a security assessment before personal information or important data is shared with other jurisdictions, but it is currently much less clear what types of entities fall under this requirement.

Localization and Transfer Assessment Requirements Related to CII Operators

Under the People’s Republic of China Network Security Law, also known as the Cybersecurity Law, personal information and important data collected and generated in the operation of critical information infrastructure operators (CII operators) is required to be stored in China and, before providing that information abroad, a security assessment is required to be passed. This new requirement caused a significant amount of concern for entities that fall within the category of CII operators because of the need to potentially restructure their data systems, but there was also a general appearance of acceptance within the business community due to the relatively targeted scope of the definition of CII operators and acknowledgement that critical infrastructures require elevated protections. (more…)

To Scan or Not to Scan: Surge in Lawsuits under Illinois Biometrics Law

by Michael G. Morgan and Mark E. Schreiber | Nov 8, 2017 | Big Data, Consumer Protection, Cybersecurity, Data breach, Data Privacy, Workplace Privacy

Although the Illinois Biometric Information Privacy Act has been on the books for almost 10 years, a recent surge in lawsuits has likely been brought on by developments in biometric scanning technology and its increased use in the workplace. At least 32 class action lawsuits have been filed in recent months by Illinois residents in state court challenging the collection, use and storage of biometric data by companies in the state. This could potentially cause a reevaluation of company strategies and development of new defenses in the use of advancing biometric technology.

Read “To Scan or Not to Scan: Surge in Lawsuits under Illinois Biometrics Law.”

ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

by Scott Weinstein | Nov 6, 2017 | Big Data, Consumer Protection, Cybersecurity, Mobile Apps, Telehealth

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria.

ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue.

Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.”