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Preparing Your Data for a Post-COVID-19 World

The US healthcare system’s data infrastructure needs an overhaul to prepare for future health crises, streamline patient care, improve data sharing and accessibility among patients, providers and government entities, and move toward the delivery of coordinated care. With insights from leaders from Arcadia, Validic and McDermott, we recently discussed key analyses and updates on the interoperability and application programming interfaces (API) criteria from the 21st Century Cures Act, stakeholder benefits of healthcare data exchange and data submission facilitation for public health purposes. Click here to listen to the webinar recording, and read on for highlights from the program. To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here. PROGRAM INSIGHTS COVID-19 is reshaping healthcare through technology. Hospitals, clinicians and payors need to use digital health tools to address the challenges of the...

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Future Forward: Data Arrangements During and After COVID-19

The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19. A variety of data sharing and collaborations have emerged in the wake of this crisis, such as: Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities CLICK HERE TO VIEW THE FULL...

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Consumer Demand in Digital Health Data and Innovation

Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that ecosystem. The essential role data strategies play make it imperative to address the data-related legal and regulatory considerations at the outset of the innovation initiative and throughout the development and deployment lifecycle so as to protect your investment in the short and long term. The Evolution of Digital Health Digital health today consists of four key components: electronic health records, data analytics, telehealth, and patient and consumer engagement tools. Electronic health records were most likely first, followed very closely by data analytics. Then telehealth deployment rapidly increased in response to both demand by patients and providers, the improved care delivery and access it offers, and more recently, the expanded...

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California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional categories of health information, including data de-identified in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), medical research data, personal information used for public health and safety activities, and patient information that is maintained by HIPAA business associates in the same manner as HIPAA protected health information (PHI). If enacted, the bill would simplify CCPA compliance strategies for many HIPAA-regulated entities, life sciences companies, research institutions and health data aggregators. Exemption for HIPAA Business Associates Presently, the CCPA does not regulate PHI that is collected by either a HIPAA covered entity or business associate. The CCPA also exempts covered entities to...

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Health Care Data Compliance in China: 4 Key Questions and Compliance Steps for Multinationals

This post was guest authored by lawyers from MWE China Law Offices, McDermott Will & Emery's strategic alliance in Shanghai.  Data compliance in China’s health care industry is multifaceted and highly sensitive, and applies to numerous types of data generated across the continuum of care. Multiple pieces of legislation prescribe complex regulatory requirements governing different types of data, and various supervisory authorities frequently conduct inspections and investigations, paying special attention to health care multinationals with operations in China. This article explores four key questions on the regulatory requirements for health care data in China, along with key compliance steps for multinationals throughout the entire life cycle of health care data, including collection, storage, transfer and use. 1. What types of health care data are regulated in China? What are the key compliance points related to these types of health care data? Data...

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2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott's 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights notable developments and guidance that health care providers, digital health companies and other health care industry stakeholders should navigate in 2019. Here, we summarize four key issues that stakeholders should watch in the coming year. For more in-depth discussion of these and other notable issues, access the full report. EU General Data Protection Regulation (GDPR) enhances protections for certain personal data on an international scale. US-based digital health providers and vendors that either (a) offer health care or other services or monitor the behavior of individuals residing in the EU, or (b) process personal data on behalf of entities conducting such activities should be mindful of the GDPR's potential applicability to their...

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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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The GDPR’s Effects in China: Comparison with Local Rules and Considerations for Implementation

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...

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Appeals Court Strikes Down Key Portions of FCC’s Onerous TCPA Rulemaking

Last week, the US Court of Appeals for the DC Circuit issued a long-awaited decision on an omnibus challenge to the FCC’s interpretation of the TCPA. While the decision provides some relief for businesses, it does not eliminate the prospect of TCPA liability and leaves important TCPA interpretive questions unresolved. Businesses should continue to be vigilant regarding consent and opt-out procedures when sending automated text messages and automated or pre-recorded calls to consumers. Continue Reading

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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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