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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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Privacy and Data Security: 2020 Considerations for the Insurance Industry

With the California Consumer Privacy Act of 2018 (CCPA) having taken effect on January 1, 2020, the privacy and data security landscape for insurance carriers, producers and insurtech (collectively, “insurers”) continues to grow more complex. A number of states have also recently passed laws regulating data security in the insurance industry, with the first transition period under a number of these laws set to end in 2020. Given the significant amount of sensitive personal information that insurers collect, process and retain, this trend of increased privacy and data security regulation within the insurance industry is likely to continue. To stay ahead of these new privacy and data security requirements, insurers need to take steps now to navigate the increasingly complex regulatory landscape. How Does the CCPA Impact Insurers? On January 1, 2020, California became the first state in the United States to enact comprehensive privacy legislation that governs...

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New Podcast: Whose Data is it Anyway? Collaboration in Digital Health

The demand for healthcare innovation is driving collaboration between formerly disparate healthcare companies and bringing in new players, such as technology companies and start-ups, into an already complex space. As companies build partnerships and pool resources – particularly healthcare data – data ownership presents numerous challenges that need to be addressed throughout the lifecycle of the collaboration. In this episode of the Of Digital Interest podcast McDermott partners Jiayan Chen and Jennifer S. Geetter explore: Key concerns for companies executing data-driven collaborations Consumer expectations surrounding data use, data privacy and their impact on digital health collaborations The role of HIPAA and federal and state regulators in regulating data use Common questions about secondary use and identifiable and deidentified data Commercialization strategies and "green flags" for identifying the right collaboration partner Click here to listen to...

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Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems. There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use of data that is distinct from the purpose for which it was originally collected. However, such secondary use is often subject to intersecting legal and regulatory regimes–including HIPAA, the Common Rule, and the Federal Food, Drug, and Cosmetic Act and its implementing regulations–that are not fully harmonized.  This lack of harmonization in requirements, coupled with the wide range of industry players involved–including regulators, academic medical centers, health systems, payers, technology companies, manufacturers and industry entities, research institutions, registries, and professional...

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The Continuing Disconnect between the Health Care Industry and OCR on HIPAA’s Risk Analysis Requirement

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...

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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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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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Many Lessons Still Need to be Learned regarding Patient Access to Health Care Information

The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the experiences of 17 individuals and processes of 50 health systems, with commentary from four medical record fulfillment administrators, to determine how the medical record request process can be improved for consumers. The Report ultimately concludes that patients and health care providers alike are in need of a well-defined process that is convenient, expedient and transparent. Background The Health Insurance Patient Portability and Accountability Act (HIPAA) does not create a uniform process for storage and production of medical records across providers, and in-turn did not create a convenient request process for patients. Generally, patients have a right to access a designated record set, which includes 1) medical records and billing records...

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