McDERMOTT DIGITAL HEALTH

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                      McDERMOTT DIGITAL HEALTH

WEBINAR SERIES: What's Next for Digital Health?
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Technology, data and consumerism have shaken up nearly every sector of the healthcare industry, from patients to providers to health insurers to pharmaceutical companies. Digital Health innovators looking to harness emerging technologies face ever-increasing legal gray areas that require future-looking solutions.


At the forefront of the transforming Digital Health landscape, McDermott works with emerging and established organizations to make sense of it all and develop creative solutions to the transactional, regulatory and compliance obstacles that can slow adoption and growth.

Meet our Digital Health Team
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AROUND THE CORNER:
DIGITAL HEALTH POST-PANDEMIC WEBINAR SERIES

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Almost overnight, the coronavirus (COVID-19) pandemic has reshaped healthcare delivery, forcing a rapid and unprecedented pivot toward virtual care. But what comes next? How does virtual care become a permanent—even a predominant part—of healthcare delivery?


Our five-part “Around the Corner” webinar series addresses the future of telehealth, digital delivery of healthcare services, data-readiness post-pandemic and more. Catch up with our conversations with digital health industry leaders to learn how they have quickly adapted in the COVID-19 world and their plans for anticipating future shifts

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AFTER THE CURVE:

THE CHANGING FACE OF HEALTHCARE

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Telehealth adoption rates exploded due the COVID-19 pandemic as the federal government knocked down long-standing obstacles to adoption and healthcare providers leveraged the solution to care for patients outside the office. The post-Coronavirus (COVID-19) landscape is unclear, but regulators have signaled that many of the changes made during the emergency period will become permanent. This likely means momentum will continue. 


Download our After the Curve report for McDermott's insights on the future of digital care.

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SPECIAL REPORT:
2019 DIGITAL HEALTH YEAR IN REVIEW

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Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product research, development and commercialization, for long-standing and new stakeholders alike. 


McDermott is pleased to bring you this review of key developments that shaped digital health in 2019 and set the groundwork for trends in 2020.

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MID-YEAR DIGITAL HEALTH REPORT

FOCUS ON MEDICARE

It has been only a little over six months, and already 2018 has been a busy year for digital health, particularly in the area of Medicare reimbursement. The Centers for Medicare and Medicaid Services (CMS), Congress, the Medicare Payment Advisory Commission, and the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) have all contributed to make 2018 extraordinary.


This Special Report includes:
•  An up-to-date review of 2018 Medicare reimbursement highlights
•  A discussion of Congressional and CMS expansion of telehealth reimbursement
•  Notes of caution about the future of Medicare reimbursement

Download the Mid-Year Digital Health Report Now
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OF DIGITAL INTEREST PODCAST


Preparing for 21st Century Cures Act and Information Blocking: Open Notes, APIs and More | Listen Now

There have been a number of recent developments surrounding the 21st Century Cures Act and information blocking rules that have the potential to greatly impact open notes sharing and regulations in healthcare.

 

With compliance dates recently pushed back to April 2021, this episode of the Of Digital Interest podcast features McDermott Health Law partners James Cannatti and Scott Weinstein, Chartis Group principal Chelsea Wyatt and associate principal Claudia Miller, and McDermott’s Chief Marketing Officer Leslie Tullio as they discuss healthcare data accessibility and other key issues healthcare providers should keep in mind to comply with new regulations, including:

 

> Scenarios in which a request for open notes might occur and key exceptions to a required response

> Guidance for providers regarding clinical notes accessibility for patients

> Compliance options for handling active requests from various input portals

> Who holds ultimate ownership for ensuring that open notes are shared when requested

> Healthcare goals with the implementation of APIs

> The types of data and notes to be shared under the USCDI standard

> Anticipated HIPAA compliance challenges associated with patient requests for shared notes

> Scenarios that will denote a need for physician training on improving their shared notes

CHECKLISTS FOR YOUR NEXT DATA COLLABORATION

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Part 1: Focus on Data

The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation (GDPR) and in the United States at the state level. Notable new state legislation includes the California Consumer Privacy Act of 2018 (CCPA) and developments in a number of state data breach notification laws that may affect organizations that handle health information. At the same time, the US federal government sought ways to reduce the regulatory burden on healthcare industry participants and increase the flow of data to promote interoperability.


This report highlights the notable actions and guidance that will shape the data privacy and security landscape for healthcare providers, digital health companies and other healthcare industry stakeholders in the coming year.

Read Part 1: Focus on Data
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NEWS & INSIGHTS

Whether you're looking to navigate new laws, policies or regulations, determine the right business collaborations, or discover ways to survive disruption, McDermott has a wealth of resources for you to get the information you need.

 

LISTEN TO THE OF DIGITAL INTEREST PODCAST

2020 Digital Health Outlook: Thoughts from CES and JPM


Culture Clashes: Getting Cross-Industry Collaborations Right

 

Whose Data is it Anyway? Collaboration in Digital Health


Around the Corner in Digital Health: What's Next for Care Coordination & Reimbursement


Breaking into Digital Health

 

Maximizing the Value of Big Data in Digital Health

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READ THE LATEST DIGITAL HEALTH NEWS

Digital Health Business Strategy: A Careful Balance


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


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

 

Challenges and Opportunities in MedTech, Innovation and Digital Health


Getting Cross-Industry Collaborations Right, Part 2: All About That Data

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Listen

Hear our latest digital health podcasts

Watch

Register for one of our webinars

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Download The Law of Digital Health Executive Summary and Discover our library of blogs.

THE LAW OF DIGITAL HEALTH

A new book about the role of digital health in the transforming healthcare landscape.

The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation (GDPR) and in the United States at the state level. At the same time, the US federal government sought ways to reduce the regulatory burden on healthcare industry participants and increase the flow of data to promote interoperability.


This report highlights the notable actions and guidance that will shape the data privacy and security landscape for healthcare providers, digital health companies and other healthcare industry stakeholders in the coming year.

 

The Law of Digital Health offers an overview of the opportunities, challenges and strategies arising from the highly dynamic components of the digital health ecosystem: health information technology, big data and data analytics, telemedicine and mobile personal engagement tools.


This book helps business leaders and their advisors understand, embrace and manage the legal implications of existing laws and regulations, as well as emerging policies that affect digital health product development, go-to-market strategies and cross-industry collaborations.

 

Spearheaded by editors-in-chief and authors Bernadette M. Broccolo and Lisa Mazur, and authored by more than a dozen McDermott Health lawyers, The Law of Digital Health provides first-of-its-kind legal information on the digital health space.


Published by the American Health Lawyers Association, The Law of Digital Health is now available to order.

Download the Executive Summary Now
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Order The Law of Digital Health Today
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#LawofDigitalHealth

OF DIGITAL INTEREST PODCAST: BREAKING INTO DIGITAL HEALTH

Sarah Hogan, Lisa Schmitz Mazur and Dale Van Demark discuss key factors both emerging and established companies should review when contemplating a move into the digital health ecosystem. 


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OF DIGITAL INTEREST PODCAST: MAXIMIZING THE VALUE OF BIG DATA IN DIGITAL HEALTH

Big data thought leaders Bernadette Broccolo and Sarah Hogan discuss the value of big data in the health care space, challenges and opportunities that health industry stakeholders face when stepping into the world of big data and proactive steps companies can take to develop robust regulatory compliance strategies.


Download from iTunes.

OF DIGITAL INTEREST PODCAST: TELEMEDICINE - THE NEW STANDARD OF CARE

Lisa Schmitz Mazur and Dale Van Demark share their perspectives on the barriers, risks and opportunities around integrating telehealth programs, and discuss the rise of telemedicine and other technological advancements in health care delivery.


Download from iTunes.

OF DIGITAL INTEREST PODCAST: THE LAW OF DIGITAL HEALTH, PART 2

Bernadette M. Broccolo and Lisa Schmitz Mazur discuss how telemedicine and personal engagement tools are transforming the health care sector.


Download from iTunes.

OF DIGITAL INTEREST Podcast: The Law of digital Health, Part 1

Listen to editors-in-chief and authors, Bernadette M. Broccolo and Lisa Schmitz Mazur discuss the changing regulatory environment and value proposition of The Law of Digital Health.


Download from iTunes.

What should readers take away from this book? (0:38)

Why is patient engagement critical to health outcomes? (0:36)

Why is this book an asset to digital health leaders? (0:34)

Why is McDermott the right firm to offer this book? (0:32)

What was most exciting about this book? (0:39)

THE RUSH ACT – ANOTHER ADVANCEMENT IN TELEHEALTH ACCEPTANCE?

As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and, consequentially, opportunities for the deployment of telemedicine technologies. As we noted then, however, improvement in the Medicare reimbursement environment for telemedicine services has been tied to a policy goal of not increasing utilization unnecessarily. Read more.

BREAKING INTO DIGITAL HEALTH: FACTORS COMPANIES MUST CONSIDER

Companies looking to enter the digital health field face myriad legal implications unique to doing business in this sector. Whether emerging or established, companies exploring health care opportunities benefit from careful planning around complex issues such as pace of development, reimbursement systems, strategies for responsible data collection and use, and effective corporate compliance programs. Read more.

Q&A: LISA SCHMITZ MAZUR ON NAVIGATING CHANGING REGULATIONS

Lisa Schmitz Mazur and Bernadette Broccolo co-authored “The Law of Digital Health,” which offers an overview of the opportunities, challenges and strategies arising from digital health. “Our goal was to put together a book that would give business leaders and legal professionals a tool to explain the digital health legal and regulatory landscape, help them understand how this landscape will evolve as digital health solutions change and illustrate how the different digital health solutions play within the broader health care space,” Ms. Schmitz Mazur said. Read more.

ILLINOIS MEDICAID PROGRAM EXPANDS TELEHEALTH REIMBURSEMENT INCREASING ACCESS TO BEHAVIORAL HEALTH AND OTHER CRITICAL SERVICES

IIn an effort to address the need for increased access to behavioral health services, Illinois has passed a series of bills that meaningfully expand the reimbursement of telehealth services delivered to its Medicaid patients. Read more. 

MAXIMIZING THE VALUE OF BIG DATA IN DIGITAL HEALTH

The interest in leveraging the value of big data in digital health has become a focus of health care industry mainstays and newcomers alike. Within a challenging regulatory landscape, it is critical for those looking to play in this space to be proactive in planning their data strategy, with an eye towards compliance planning and solid due diligence to maximize its value. Read more. 

TELEMEDICINE – THE NEW STANDARD OF CARE

As use cases like this continue to be integrated into health care delivery and familiarity builds around how telemedicine can be used effectively, expectations shift around the standard of care and new questions arise around the risks of integrating—or failing to integrate—telehealth programs. Read more.

BLAZING NEW TRAILS IN HEALTH CARE AND TECHNOLOGY INNOVATION VENTURES

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and investment among stakeholders or all sorts. Read more.

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. Read more.

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. Read more.

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CONNECT WITH OUR DIGITAL HEALTH TEAM

Stephen W. Bernstein

PARTNER & LEADER
DIGITAL HEALTH PRACTICE

MCDERMOTT WILL & EMERY 

Lisa Mazur

PARTNER & LEADER
DIGITAL HEALTH PRACTICE

MCDERMOTT WILL & EMERY 

Bernadette M. Broccolo

Jiayan Chen

Amanda Enyeart

Jennifer Geetter

Daniel Gottlieb

Ryan S. Higgins

Marshall E. Jackson

Anisa Mohanty

Amy C. Pimentel

Michael W. Ryan

Dale C. Van Demark

Scott A. Weinstein

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©2020 McDermott Will & Emery

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The Law of Digital Health

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