HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Digital Health
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Three Digital Health Trends Affecting Investors in 2021

Private equity deal volume hit a low in the first half of 2020 as the pandemic slowed the US and global economies. But toward the end of the year, deals began picking back up, particularly in the digital health space.

COVID-19 forced healthcare providers to shift from in-person to virtual care, and technology was the vehicle to make that switch possible. Investors noticed, and more deals focused on companies specializing in telehealth, remote patient monitoring and other technology platforms that facilitate communication among specialists.

Expect this trend to continue in 2021, and keep these three factors in mind when evaluating the digital health landscape.

Easing of Laws and Regulations Surrounding Telehealth and Digital Health

Both telehealth and digital health are highly regulated, as every state has laws and regulations that govern how care is provided virtually and how those services are billed. In response to the pandemic, we’ve seen flexibility with these laws and regulations, and the Biden administration has signaled that it might make some flexibilities permanent.

Investment opportunities will likely increase as a result of the Biden administration’s willingness to lower some of the longstanding barriers to coverage and payment for virtual services, including telehealth, remote patient monitoring and other related services. That’s a positive sign for firms looking at healthcare through the lens of a technology solution.

Reallocation of Resources Due to Vaccine Rollout

Since the onset of the pandemic, labs have conducted a huge volume of testing and have had to ramp up personnel and other [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health Systems: Legal and Financial Trends

Leading professionals Gary Burke (Partner, Forensics, EY), Sandy DiVarco, and Jennifer Geetter (Partners, McDermott Will & Emery), Mike J. India (Managing Director, EY-Parthenon) and Matthew Weiss, MD (EY-Parthenon Managing Director, Health care, Ernst & Young LLP) discussed critical legal, regulatory and financial trends facing hospitals and health systems with moderator, Charlie Buck (Partner, McDermott Will & Emery).

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Hospital and Health System: Legal and Financial Trends, click here to access the full webinar.

Access the PDF here.

LONG TERM CHANGES TO REGULATORY RESTRICTIONS
Many regulatory requirements were relaxed in respond to the COVID-19 public health emergency. There has been much discussion regarding the extent to which these restrictions will “snap back” after the end of the public health emergency, because the public health emergency has highlighted the value of certain delivery models.
“I think there is going to be streamlining in some of these regulatory structures. So when we look at what’s going to be durable, hopefully we will see changes in the process that will make it easier for hospitals and other providers to respond and to remain on top of things,” said Sandy DiVarco, Partner, McDermott Will & Emery. [...]

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McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum

 

 

Top industry executives BJ Moore, Executive Vice President and Chief Information Officer, Providence St. Joseph Health; Dr. Ali Parsa, Chief Executive Officer, Babylon Health; and Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, discussed the evolving doctor-patient relationship and the digitized data and technology convergence with healthcare delivery and payment along with moderators Dale C. Van Demark, Partner, McDermott Will & Emery; Rachel S. Hall, Partner, Digital Health Leader, EY; Stephen W. Bernstein, Partner, McDermott Will & Emery; and Lisa Schmitz Mazur, Partner, McDermott Will & Emery. They also provided insight into 2021’s regulatory considerations affecting healthcare innovation and its solutions.

Below are the top takeaways for McDermott Will & Emery and EY during the 2021 J.P. Morgan Healthcare Conference: Digital Health Pioneers Forum, click here to access the full webinar.

Access the PDF here.

CARE OF THE FUTURE
We are only seeing the beginning of the decentralization of care through information technology; but that shift is how scalable solutions to our health care challenges will develop. “Care delivery at home, where we can send patients home and remotely monitor them—eventually that will evolve to things like wearables -IoT devices- that we may have in our clinical settings. We’re seeing the hospitals play such [...]

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Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry

How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching effects for dealmakers, executives and investors.

Eric Zimmerman, global head of McDermott’s Health Industry Advisory Practice Group, moderated this discussion that featured insights from Susan Van Meter, executive director at AdvaMedDx; Rodney Whitlock, PhD, vice president at McDermott+Consulting; and Brian Fortune, senior managing director at Farragut Square Group.

Below are the top takeaways for Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry, click here to access the full webinar.

Access the PDF here.

President-Elect Biden’s legislative experience likely will help him reach across the aisle and engage with Republican congressional leadership to advance policy goals. “Biden spent his whole career on the Hill before he became vice
president, so he really understands how his colleagues tick, and he particularly understands the process of how the Hill makes sausage,” Mr. Fortune said. “That’s something that you can’t really say about either President Obama or President Trump. So, not surprisingly, you saw that when they had all the majorities lined up in their favor, they could move stuff, but when they didn’t, it became a little harder.”

With only a narrow projected majority in the US House of Representatives, Democrats will need to work together more effectively and reach [...]

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Life Sciences Dealmaking Symposium: Powering through the Pandemic: Trends in Early-Stage Investment

The pursuit of progress during these unprecedented times has led to a surge in life sciences investment and funding for early stage companies. Investors are on the lookout for the next big innovation while also navigating new ways of sourcing and managing portfolio companies. Our panel of experienced early-stage investors discussed the top trends in this push for advancement, including sectors attracting the most dollars in today’s challenging business landscape, key issues that early stage investors are watching as they source and vet new investment opportunities, steps that executives of early-stage companies can take to articulate their value and attract investors, and more.

McDermott partners Todd Finger and Joanna Lin moderated this discussion featuring Eric Aguiar, MD, partner at Aisling Capital; Dr. Andrew ElBardissi, partner at Deerfield Management; and Marian Nakada, vice president of venture investment at J&J Innovation.

Below are the top takeaways for Life Sciences Dealmaking Symposium: Powering through the Pandemic: Trends in Early-Stage Investment, click here to access the full webinar.

Access the PDF here.

COVID-19 fundamentally changed the process for evaluating new investment opportunities, Dr. ElBardissi said. “Meeting face-to-face with the management team, kicking the tires, touring the facility—those are intangible factors
that are very difficult to replace in this corporate environment,” he said. “Candidly, the bar has gotten significantly higher, as you think about our inability to conduct diligence the way we would like and as you think about all the constraints in the current environment.”

[...]

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Life Sciences Dealmaking Symposium: New Factors in the Mix: Diligence in the Time of COVID-19

Navigating the ever-changing global life sciences deal landscape has become more challenging in the post-pandemic world. Conducting virtual inspections and examining security and privacy risks for remote working and new operating procedures will be central to evaluating current and future collaboration partners and targets. Thinking quickly yet carefully is essential for successfully adapting to this new normal. This panel explored the critical issues that executives and investors should watch out for in a post-COVID-19 world.

McDermott partner Michael Siekman moderated this discussion featuring Tom Brida, general counsel and chief compliance officer at Invitae; Dr. Anna French, partner at Qiming Venture Partners; Chuck Wilson, president and CEO of Cogent Biosciences; McDermott attorney Jennifer Bock; and Laura Jehl, global head of McDermott’s Privacy and Cybersecurity Practice Group.

Below are the top takeaways for Life Sciences Dealmaking Symposium: New Factors in the Mix: Diligence in the Time of COVID-19, click here to access the full webinar.

Access the PDF here.

The COVID-19 pandemic has forced dealmakers to conduct due diligence virtually, using tools such as videoconferencing and virtual data rooms more than ever before. In some ways, this shift has actually made the due diligence process more efficient, the panel observed. With the complications of travel replaced with the convenience of videoconferencing, some aspects of the process are moving along more quickly than before the pandemic shutdown.

Despite increased efficiencies, lack of in-person interactions may impact deal pipelines long-term as investors move from doing deals [...]

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Advancing Primary Care in Washington, DC, in 2021

Guest post by Mara McDermott, Vice President at McDermott+Consulting.

With the 2020 election almost in the rearview mirror, clinicians and policymakers alike are turning their attention to the 2021 agenda. For primary care providers, 2021 will hopefully bring COVID-19 recovery and response efforts, additional opportunities to pursue value-based payment arrangements, and ongoing deployment of telehealth and virtual technology.

The 2020 presidential election is expected to bring about a change in administration. However, the “blue wave” Democratic sweep projected by some pundits and pollsters failed to materialize. Instead, in Washington, DC, we will have a closely divided US Senate, with the final balance of power to be determined by two run-off races in Georgia. The US House of Representatives will remain in Democratic control, but by a smaller margin. The narrow margins in the House and Senate will likely constrain the extent to which Democrats are able to advance progressive policy changes. Instead, both sides of the political aisle in Congress are likely to focus on bipartisan areas of agreement. For primary care clinicians, this environment may be encouraging, as members of both parties share goals around protecting and advancing primary care across the country.

COVID-19 Response

When the new Congress begins and President-Elect Biden is inaugurated in January 2021, COVID-19 relief is expected to be at the top of the agenda. Expect President-elect Biden and the incoming Congress to pursue economic and public health relief. Clinicians across the country who have faced depressed revenue as [...]

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After the Curve Podcast: Focus on Health Insurance and Coverage

COVID-19 has catalyzed significant changes in the patterns of healthcare delivery, with the potential for long lasting effects on payors as a result. On this episode of the After the Curve podcast, we discuss how the COVID-19 pandemic may shift the healthcare coverage and payment landscape as well as how it may boost integration among payors and providers. McDermott’s Chief Marketing Officer Leslie Tullio is joined by Kate McDonald and Ankur Goel to discuss relevant topics for both payers and the healthcare industry more broadly, including:

  • How COVID-19 is changing healthcare utilization patterns in the US and the impact of that disruption on insurers
  • The reaction from health plans to the financial impact of COVID-19 on providers
  • The impact of telehealth and regulatory waivers at the state and federal levels on the payor market
  • Top lessons that payors have learned from the pandemic and subsequent next steps
  • Opportunities for healthcare leaders to synthesize where we are today
  • Key takeaways for payors moving forward from the pandemic

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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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