McDermott Partners Recognized As Digital Health Power Players

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

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

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

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

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.




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