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Order now: The Law of Digital Health Book

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.mwe.com/lawofdigitalhealth to order this comprehensive legal and regulatory analysis, coupled with practical planning and implementation strategies. You can also download the Executive Summary and hear more about how Digital Health is quickly and dynamically changing the health care landscape. Explore more!

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

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.

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UK Government Issues Cybersecurity Guidance for Connected and Automated Vehicles

On 6 August 2017, the UK government released ‘The Key Principles of Vehicle Cyber Security for Connected and Automated Vehicles’, guidance aimed at ensuring minimum cybersecurity protections for consumers in the manufacture and operation of connected and automated vehicles. Connected and automated vehicles fall into the category of so-called ‘smart cars’. Connected vehicles have gained, and will continue to gain, adoption in the market and, indeed, are expected to make up more than half of new vehicles by 2020. Such cars have the ability through the use of various technologies to communicate with the driver, other cars, application providers, traffic infrastructure and the Cloud. Automated vehicles, also known as autonomous vehicles, include self-driving features that allow the vehicle to control key functions–like observing the vehicle’s environment, steering, acceleration, parking, and lane changes–that traditionally have been performed by a human driver....

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OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently posted guidance (OCR guidance) clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a covered entity customer to protected health information (PHI) maintained by the vendor on behalf of the customer. Such “information blocking” could occur, for example, during a contract dispute in which a vendor terminates customer access or activates a “kill switch” that renders an information system containing PHI inaccessible to the customer. Many information vendors have historically taken such an approach to commercial disputes. Read full article here.

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Augmented Reality

If you haven’t heard about newest gaming craze yet, it’s based on what is called “augmented reality” (AR) and it could potentially impinge on your home life and workplace as such games allow users to “photograph” imaginary items overlaid with objects existing in the real world. An augmented reality game differs from “virtual reality” in that it mixes elements of the real world with avatars, made up creatures, fanciful landscapes and the like, rather than simply presenting a completely fictional scenario. Whether you play such games yourself or are merely existing in nearby surroundings, here are few things to think about as an active participant, and some tips regarding Intellectual Property and confidentiality issues that arise from others playing the game around you. Augmented reality games are typically played on a smartphone app and some of them allow the user to capture images of the player’s experience and post it on social media, text it to friends or...

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China Released the Latest Classification Catalogue of Telecommunications Services (2015 Revision)

On December 28, 2015, the Ministry of Industry and Information Technology of China released the newly revised Classification Catalogue of Telecommunications Services, which is due to take effect as of March 1st, 2016. This round of revision has long been awaited since its last amendment in 2003, and is expected to reflect the advancement and emergence of new technologies and business models in the telecommunication field as well as to help keep new telecommunication business models under the regulatory radar.   Read the full China Law Alert.

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National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments.  The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that will allow for the freer flow of health-related data by and among providers and patients.  The use of technology to capture and understand health-related information and the strategic sharing of information between health industry stakeholders and its use is widely recognized as critical to support patient engagement, improve quality outcomes and lower health care costs. On April 3, 2015, the Federal Trade Commission issued coordinated comments from its Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection and Bureau of Economics.  The FTC has a...

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Any Progress? The Draft Data Protection Regulation Celebrates its Third Anniversary

On the third anniversary of the EU Commission’s proposed new data protection regime, the UK ICO has published its thoughts on where the new regime stands. The message is mixed: progress in some areas but nothing definitive, and no real clarity as to when the new regime may come into force. The legislative process involves the agreement of the European Commission, the European Parliament and the Council of Europe (representing the governments of the member states). So far the European Parliament has agreed its amendments to the Commission’s proposal and we are still waiting for the Council to agree it’s amendments before all three come together and try and find a mutually agreeable position. The Council is guided by the mantra “nothing is agreed until everything is agreed”, and so even though there has been progress with the Council reaching “partial general agreement” on international transfers, risk-based obligations on controllers and processors, and the...

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Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed its expanded reach in the United States, and Canada’s far-reaching anti-spam legislation takes full effect imminently. As European authorities grappled with the draft data protection regulation and the “right to be forgotten,” the African Union adopted the Convention on Cybersecurity and Personal Data, and China improved the security of individuals’ information in several key areas. Meanwhile, Latin America’s patchwork of data privacy laws continues to evolve as foreign business increases. This report furnishes in-house counsel and others responsible for privacy and data protection with an overview of key action points based on these and other 2014 developments, along with advance notice of potential trends in 2015. McDermott will...

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GPEN Publishes Privacy Sweep Results

On 10 September 2014, the Global Privacy Enforcement Network (GPEN) published the results of its privacy enforcement survey or “sweep” carried out earlier in 2014 with respect to popular mobile apps.  The results of the sweep are likely to lead to future initiatives by data protection authorities to protect personal information submitted to mobile apps. The purpose of the sweep was to determine the transparency of the privacy practices of some 1,211 mobile apps and involved the participation of 26 data protection authorities across the globe.  The results of the sweep suggest that a high proportion of the apps downloaded did not sufficiently explain how consumers’ personal information would be collected and used. Background GPEN was established in 2010 on the recommendation of the Organisation for Economic Co-operation and Development.  GPEN aims to create cooperation between data protection regulators and authorities throughout the world in order to...

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