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McDermott Partners Recognized As Digital Health Power Players

by McDermott Will & Emery | Aug 13, 2021 | Telehealth

Washington (August 11, 2021) – McDermott Will & Emery partners Jennifer Geetter and Vernessa Pollard have been recognized within an Insider profile on the “9 behind-the-scenes players who can make or break your digital-health startup.” The pair discussed advising young companies on the regulatory hurdles they have to clear before tackling the healthcare market.

As part of the Firm’s industry-leading health practice, Jennifer advises digital health companies on the development, delivery and implementation of innovative healthcare solutions. Vernessa leads medical device and technology companies through US Food and Drug Administration (FDA) regulations to bring products to market.

Vernessa explored with Insider how more tech companies are spreading into healthcare. These companies need assistance discussing the FDA’s newest regulations, including machine learning oversights or health-data privacy rules. If businesses are not knowledgeable about their regulatory requirements, it can make or break their investments.

“We have a number of what we’d consider to be nontraditionally FDA regulated entities, such as the large tech companies and even hospitals and healthcare providers, that are entering this space because they’re developing new tools or technology that may trigger FDA requirements,” Vernessa noted.

Jennifer explained that it’s not always clear if decade old FDA laws apply, so she advises her clients to prioritize building trust with patients through an emphasis of privacy and cybersecurity protection.

“There’s something about the intimacy of the standard doctor-patient relationship when you’re sitting across the room from your doctor that breeds trust,” Jennifer said. “When you’re in a digital healthcare system with distance, you don’t necessarily have that.”

McDermott Will & Emery is the nation’s leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers “Best Law Firms,” Chambers USA, The Legal 500 US and Law360. The practice was also recognized by Chambers as “Health Team of the Year” in 2010, 2013, 2017 and 2019. McDermott has also held the top spot in PitchBook’s League Tables as the most active firm for healthcare private equity since 2017.

CMS Addresses Virtual Care Expansion in CY 2022 Medicare Physician Fee Schedule Proposal

by Amanda Enyeart, Marshall E. Jackson, Jr., Lisa Mazur and Dale C. Van Demark | Jul 27, 2021 | Telehealth

On July 23, 2021, the Centers for Medicare & Medicaid Services (CMS) published its annual proposed changes to the Medicare Physician Fee Schedule (MPFS), which include several key telehealth and other virtual care-related proposals. The proposals address long-standing restrictions that have historically limited the use of telehealth and virtual care, including geographic and originating site restrictions, and limitations on audio-only care, as well as coverage extensions for some services added during the COVID-19 public health emergency.

These proposals include:

The implementation of the Consolidated Appropriations Act, 2021 (CAA) in-person visit requirement for mental health services that either do not meet Medicare’s typical geographic restrictions or occur when the originating site is the patient’s home, regardless of geography
The ability for certain mental health services to be delivered via audio-only communications when patients are located in their homes (however, in these cases, the provider would also be required to comply with the in-person visit requirement described above)
The extension of coverage of the services temporarily added to the Medicare telehealth services list (Category 3 services) through the end of CY 2023 to allow more time for evaluation, and the rejection of proposed new, permanent Medicare telehealth services
The permanent adoption of HCPCS Code G2252 for extended virtual check-ins, which was established on an interim basis in the CY 2021 MPFS.

Read the full article here.

State Privacy Patchwork Spreads with Signing of Colorado Privacy Act

by Austin Mooney, Amy C. Pimentel, David Saunders and Frances Forte | Jul 9, 2021 | Consumer Protection, Data Privacy, General Interest

On July 7, 2021, Colorado Governor Jared Polis signed the Colorado Privacy Act (CPA) into law, the latest in the recent wave of state privacy legislation but unlikely to be the last. The CPA will take effect July 1, 2023, six months after Virginia’s Consumer Data Protection Act (CDPA) and the California Privacy Rights Act (CPRA) become effective. Organizations subject to the new Colorado law will have to prepare for new consumer rights and restrictions with respect to Colorado consumers’ personal data. What follows are key takeaways from the CPA and the implications for businesses grappling with the changing privacy landscape in the US.

Applicability and Exemptions

Not all organizations will be covered by the new CPA. To be subject to the law, an organization must do business in Colorado and meet one of the following requirements:

The organization processes data on 100,000 or more Colorado consumers annually.
The organization processes data on 25,000 or more Colorado consumers annually and “sells” any personal data.

This applicability threshold sets a relatively high bar, and many companies that are subject to the California Consumer Privacy Act of 2018 (CCPA)/CPRA may not meet these thresholds in Colorado.

There are a number of exemptions and limitations built into the Colorado law. Personal data regulated under existing federal privacy regimes, such as the Health Insurance Portability and Accountability Act (HIPAA), will be exempt from the CPA, as will personal data about employees and others “acting in a commercial or employment context.” Further, the CPA’s substantive requirements will not limit organizations’ ability to process data for legal compliance, fraud prevention, security, contract fulfillment or any “internal operations that are reasonably aligned with the expectations of the consumer based on the consumer’s existing relationship” with the organization.

Substantive Rights Largely Mirror Other State Privacy Laws

The CPA establishes a number of substantive rights that Colorado consumers will have with respect to their personal data. In general, these rights mirror those in the existing laws in California and Virginia, including the following:

Notice. Covered organizations will be required to disclose data collection and processing details in their public-facing privacy policies. In addition, a new “duty of purpose specification” requires that companies identify the “express purposes for which personal data are collected and processed.” Whether existing privacy policies are sufficiently “express” for these purposes will be an important consideration for organizations under the CPA and one that will likely lead to both confusion and potential regulation in the future.
Access, Correction and Deletion. Consumers will have the right to access, correct and delete their personal data. For the right to access, businesses will be required to provide data in a portable format where feasible.
Opt Out. Consumers have the ability to opt out of data “sales,” targeted advertising and high-risk automated “profiling.”
Opt In. As with the CDPA, businesses must seek opt-in consent before collecting or processing “sensitive personal data,” which includes data revealing an individual’s race, ethnicity, religious beliefs, [...]

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Potential Applications of AI in Health Care

by Bernadette M. Broccolo | Jun 23, 2021 | Cloud, Consumer Protection

Artificial intelligence (AI) offers powerful new modalities for improving care delivery and access, harnessing previously untapped data, and reducing error and waste. As AI applications proliferate, health industry stakeholders are increasingly exploring how they might integrate these solutions to benefit their providers and patients. This article includes just a small sample of potential applications of AI to address a broad range of needs in healthcare care and life sciences.

To view the full article, “Potential Applications of AI in Healthcare,” click here.

For a deeper dive into the role of AI in healthcare and the board’s governance responsibility, read our June 2021 Health Law Connections article.

Fiduciary Engagement in Artificial Intelligence Innovation: A Governance Imperative

by Bernadette M. Broccolo and Michael W. Peregrine | Jun 10, 2021 | Big Data

For most healthcare and life sciences companies, investment in and deployment of AI technology is expected to be a critical strategic component for the foreseeable future. Effective, ongoing governance oversight of AI will be a critical organizational concern for companies, and the governance framework itself must reflect and be able to accommodate the highly dynamic nature of AI. Establishing a framework for board decision making and oversight at the earliest possible stage of an organization’s development and implementation of its AI strategy will contribute significantly to the board’s ability to fulfill its fiduciary responsibilities and thereby enhance the AI initiatives’ trustworthiness and prospects for success.

Click here to read the full article.

Originally published in the June 2021 issue of Health Law Connections, produced by the American Health Law Association.

McDermott Earns “Elite” Firm Designation and 12th Consecutive Band 1 National Ranking from Chambers USA

by McDermott Will & Emery | Jun 3, 2021 | Uncategorized

International law firm McDermott Will & Emery is pleased to announce its Healthcare Group received its 12th consecutive national Band 1 ranking in the 2021 edition of Chambers USA. The team also earned Band 1 state-level healthcare rankings in California, Florida, Illinois, Massachusetts and Washington, DC. Additionally, the Firm earned the national Spotlight Table ranking for the Privacy and Data Security: Healthcare category. Overall, the Firm saw a 25% increase in the number of new partners recognized, bringing the total to 37.

Chambers praised McDermott’s Health Industry Advisory practice, describing the team as “top-notch” and “very knowledgeable, responsive and practical.” Interviewees also drew attention to the Firm’s “incredible roster of clients.”

Clients provided similarly impressive remarks, noting our team’s deep bench strength and specialties. “McDermott is the best – they have the deepest knowledge and the most subspecialists” and “the firm consistently produces high-value work. It does a great job quickly analyzing and reporting out on regulatory and legislative changes.” One interviewee recognized “McDermott’s healthcare practice is unparalleled. It has experts on every corner of the industry.”

This year was particularly important and challenging for the health industry. Our passion and dedication to help clients achieve and surpass their business goals, while delivering the highest level of care – no matter the state of the healthcare landscape – was most important to us. “We are honored that Chambers USA again recognized our unwavering commitment to clients,” said Eric Zimmerman, global lead of McDermott’s Health practice. “After the challenges over the last year, these accolades feel particularly gratifying, because they reflect that we successfully served our clients on the front lines of the COVID-19 response as they advanced their missions and kept their businesses moving forward.”

Of the 37 Chambers USA recommended healthcare lawyers, 12 were ranked in Band 1, including Bernadette Broccolo, Stephen W. Bernstein, Ira Coleman, Charles Buck, John M. Callahan, Gary Scott Davis, Christopher M. Jedrey, James F. Owens, Michael W. Peregrine, Kerrin Slattery, Jerry J. Sokol and Eric Zimmerman. Additional lawyers were recognized across eight states, including seven lawyers who were added to the rankings for the first time and six who advanced from the previous year.

McDermott Will & Emery is the nation’s leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers “Best Law Firms,” Chambers USA, The Legal 500 US, and Law360. The practice was also recognized by Chambers as “Health Team of the Year” in 2010, 2013, 2017 and 2019. McDermott has also held the top spot in PitchBook’s League Tables as the most active firm for healthcare private equity since 2017.

Read the full details about the Firm’s rankings and editorial commentary.

ABOUT CHAMBERS USA

Chambers USA rankings and editorial commentary are based on independent research, and interviews with clients and other purchasers of legal services. Chambers & Partners is one of the premier directories for legal services and in a survey of 20,000 in-house counsel over half [...]

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Transfers of Health Data from the European Union to the United States in a Post-Schrems II World

by Amy C. Pimentel and Romain Perray | May 20, 2021 | Data Privacy, Data Transfers/Safe Harbor/Privacy Shield

The European Data Protection Board and a number of data protection authorities in EU Member States have issued guidance on how to safeguard EU/US data transfers post-Schrems II.

Click here to read the full article in our latest International News.

Access To Digital Health Applications And Digital Care Applications In Germany

by Stephan Rau | May 17, 2021 | Data Privacy, Mobile Apps, Telehealth

On 20 January 2021, the German Federal Cabinet approved the draft law on the digital modernization of healthcare and nursing care. The draft has been criticized for not taking into account lessons learned from the implementation of the 2019 digital health applications law.

The legally enforceable right of patients insured in the Germany statutory healthcare system (SHI) to be able to access digital health applications (DiGAs) was included in the German SHI code (SGB V) at the end of 2019.

DiGAs are low-risk medical devices (risk class I and IIa) that are primarily based on digital technologies and support the detection, monitoring, treatment, or alleviation of diseases, injuries, or disabilities. Under the SGB V, DiGAs have to be approved by the German Federal Institute for Drugs and Medical Devices (BfArM) and included in the DiGA List before doctors can prescribe them to their patients on an individual basis and at the SHI’s expense. Among the DiGAs listed by BfArM since the first listing in October 2020, are those that support patients with light depression, insomnia, obesity, or tinnitus.

Top Takeaways | Cybersecurity & Insurance Coverage in the Age of Telehealth: Understanding and Mitigating Your Risk

by McDermott Will & Emery | Apr 20, 2021 | Cybersecurity, Data breach, Data Privacy, Telehealth

With more frequent and more severe ransomware attacks against health care platforms and vendors and the increasing use of telemedicine, it is critical to understand how to proactively defend your organization using robust legal, regulatory and cyber-coverage strategies. In this webinar, McDermott partners Dale Van Demark and Edward Zacharias joined Brett Buchanan of Marsh & McLennan Agency and Larry Hansard of Gallagher USA to explore the intersection of telemedicine and cybersecurity. Our panelists offered attendees a road map for navigating this rapidly changing space, including practical strategies for shoring up their defenses and addressing potential risks to their businesses.

Providers engaging in telemedicine should consider three critical areas of insurance coverage: medical professional liability, technology errors and omissions, and cyber/privacy liability. “Several carriers have packaged these three important coverages into a one-policy format, referred to as a virtual health program,” Hansard said.
A medical professional liability program should include incident reporting, punitive damages, and sexual abuse and molestation. The latter may seem surprising in a telemedicine context, but is important given reports of inappropriate patient behavior during telemedicine encounters, Hansard said.
New telehealth technologies, such as AI chatbots for patient intake, create new and more complex bodily injury exposures, Buchanan said. “Working with an insurance underwriter that understands these nuances is absolutely key,” he said. In addition to bodily injury, coverage should include technology errors and omissions, cyber liability and general liability.

Click here for the full list of highlights.
Click here to view the full webinar.

Telehealth and Prescribing: What’s Permissible in Your State?

by McDermott Will & Emery | Mar 2, 2021 | Telehealth

Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings.

Our new interactive map explores the standards and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter in all 50 states and the District of Columbia. Key issues addressed in the survey include:

In what states are asynchronous solutions permitted?
What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
What are state rules on prescribing via audio-visual encounters or audio-only encounters?
Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?

Click here to access the map and download the full report.