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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are “implementing agencies” for purposes of the Memorandum. Submission of Agency Plan to OMB The “implementing agencies” have 180 days to submit to OMB their plans for addressing the Memorandum. An agency’s plan must: (1) identify any statutory authorities...

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Reviewing Key Principles from FDA’s Artificial Intelligence White Paper

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically ML, are “techniques used to design and train software algorithms to learn from and act on data.” FDA’s proposed approach would allow modifications to algorithms to be made from real-world learning and adaptation that accommodates the iterative nature of AI products while ensuring FDA’s standards for safety and effectiveness are maintained. Under the existing framework, a premarket submission (i.e., a 510(k)) would be required if the AI/ML software modification significantly affects device performance or the device’s safety and effectiveness; the modification is to the...

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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program. There are two criteria for inclusion in the Breakthrough Device Program: The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients....

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Digital Health in the UK: The New Regulatory Environment Under the Medical Device Regulation

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan, which set out ambitious aims for the acceleration and adoption of digital health and AI, particularly in primary care, outpatients and wearable devices. Although these developments are encouraging to developers, there is still no clear framework for reimbursement or tariffs for digital health tools and AI. At the same time, the plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In fact, there is some risk that while regulatory landscape is moving quickly, the pricing environment is still a...

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Live Webinar: Developing and Procuring Digital Health AI Solutions: Advice for Developers, Purchasers and Vendors

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...

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Surfing “Tech’s Next Big Wave”: Navigating the Legal Challenges in Digital Health

Fortune’s April 2018 cover story, “Tech's Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well as how patients manage their ongoing health—and as patient demand for health innovation increases, more companies seem eager to hop on the digital health bandwagon. The article provides a thoughtful, realistic (and somewhat sobering) perspective on digital health innovation’s successes and other results to date. It also quite effectively uses real world stories to convey the human dimension of digital health. One is the story of a mother who manually sampled and recorded her son’s glucose levels 20 times a day before an automated monitoring system connected to a mobile app allowed them both to live their lives without constant interruption by this critical care management function. Another describes use of an artificial intelligence...

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

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. ...

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

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.

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Artificial Intelligence in Health Care: Framework Needed

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, the functioning of search engines, and online advertising techniques on commercial and political decisions. The alleged “hacking” of the 2016 US presidential election, and the concerns about such activities in the 2017 European elections, will only heighten the interweaving discussions on free speech, national sovereignty, cyber security and the nature of privacy. The use of artificial intelligence and machine-learning technologies has only added to the list of issues and areas of concern. The consequences of automobile accidents involving “self-driving”...

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