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360 Diligence for Digital Health Investments: What to Watch in Today’s Market Trends

Contributors: Dudley Baker, Managing Director, Holihan Lokey | Luiz Greca, Managing Director, Holihan Lokey | Chris Schickling, Managing Director, Gallagher

The digital health industry is complex and highly regulated, presenting unique challenges for investment in this space – especially for investors new to the healthcare industry. Healthcare companies have business lines and regulators that do not exist in other sectors of the economy, making it crucial to work with advisors that understand the value proposition of a healthcare business, where value resides amongst potential targets, and how valuations may vary. These complexities, coupled with current market trends, amplify the need for comprehensive diligence strategies to stratify risk and maximize value from advisors that understand the nuances of the healthcare sector.

In this article, we discuss the top three trends we’re seeing in digital health investment and how Gallagher, Houlihan Lokey, and McDermott Will & Emery can position your organization for success from pre-acquisition diligence to post-close operations.

Heightened Scrutiny on Healthcare Transactions and Physician Practice Management Structures

Healthcare transactions and physician practice management structures (sometimes referred to as the “friendly PC model”) are facing heightened scrutiny at both the state and federal levels. Regulators are imposing new requirements on parties and applying stricter transaction review standards, creating hurdles for healthcare investors and companies that may impact their ability to execute transactions and management relationships, and upend standard transaction timelines. For example, state laws like the recently passed and subsequently vetoed California’s AB 3129 seek to implement transaction notification and approval requirements that could present new obstacles to closing transactions and may extend pre-closing timelines. This bill would have also changed in the ways in which management companies and physician groups arrange for support services. Although Governor Newsom vetoed AB 3129, there is a newfound wave of support at both the state and federal levels to further regulate private investment in, and control of, healthcare organizations that continues to gain momentum. Oregon and Massachusetts are examples of other states that have considered similar legislation.

McDermott’s specialized focus on healthcare dealmaking and our scrutiny of the federal and state regulatory landscape helps investors and health companies stay ahead of legal developments, understand implications of proposed regulations, ensure compliance with federal and state agencies, and chart a course to move transactions through the review process efficiently.

Strengthening Cybersecurity

The healthcare sector is particularly vulnerable to cybersecurity issues and continues to be highly targeted for cybercrime. The health sector has historically under-invested in cybersecurity personnel and technology and is increasingly being targeted by sophisticated ransomware and other malicious threat actors.

In recent years, attacks on healthcare providers, insurers, and health technology vendors have resulted in catastrophic cyberattacks that have compromised patient data, resulted in a wave of class action litigation, and resulted in regulatory scrutiny and new regulations of the healthcare industry. These incidents are also incredibly expensive to contain, investigate, and remediate. In fact, according to the 2024 IBM-Ponemon Cost [...]

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Available Now – 2019 Digital Health Year in Review

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. Lawmakers and regulators made meaningful progress towards modernizing the existing legal framework to both protect patients and consumers and encourage continued innovation, but these efforts still lag behind the pace of digital health innovation. As a result, some obstacles, misalignment and ambiguity remain, and 2020 will likely be another year of significant legal and regulatory change.

Click here to read our review of key developments that shaped digital health in 2019 and set the groundwork for trends in 2020.

 




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Getting Cross-Industry Collaborations Right, Part 1: A Transactions Perspective

Healthcare is facing an age of disruption from new market entrants and players outside the traditional healthcare paradigm. Unexpected partnerships are bringing fresh solutions to market and changing how business is done and care is delivered.

Many of these new partnerships are arising in conjunction with innovation investments by hospitals and health systems (HHSs). HHSs have always been a source of significant innovation through research and other avenues, but traditionally this work has been largely decentralized. Today, HHSs are formalizing their innovation efforts and finding ways to capitalize on those opportunities—which are abundant, thanks to HHSs’ physician workforce, research infrastructure, and access to patients and their data. These centralized innovation incubators make it easier for non-traditional players, such as tech companies, to pool resources with an HHS and bring game-changing solutions to market in an expedited fashion.

Whether they occur through an innovation center, cross-industry ventures in the healthcare sphere are still in their infancy. As such, they pose a number of challenges that require careful planning and a flexible mindset.

Vet Your Opportunities Thoroughly

In today’s push for value-driven transformation, HHSs and other health industry stakeholders have hundreds if not thousands of opportunities for partnerships knocking on their door. Diverse players, from tech vendors to start-ups to private equity firms, are queuing up for a chance to participate in the burgeoning health sector.

Faced with these abundant—and often novel—opportunities, HHSs have the task of sorting through their options and developing an efficient process to vet, select and pursue them. Too many choices is a good problem to have, but HHSs nonetheless face challenges as they determine the best way to triage potential partnerships and ventures. Key infrastructure components at HHSs include education of and buy-in by governing board, development of investment guidelines that align with mission, and building the innovation structure and team (often with contributors who come from outside of “traditional healthcare”). Once that infrastructure has been established, the HHS will be able to evaluate and pursue innovative ventures better and faster, in turn bringing solutions to market and to patients more quickly.

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Telemedicine Collaborations and Partnerships: Key Considerations for Success

Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present a variety of regulatory, logistical and operational concerns that should be strategically addressed from the ideation stage of the collaboration onward.

Early-Stage Considerations

The strategy behind the collaboration should be developed with an eye towards the duration of the relationship and the development of mutually beneficial goals and objectives that are clear and measurable. Each party should be transparent about their capabilities and strategic vision at the outset of the collaboration talks to avoid any surprises or disappointments deeper in the future. Questions for potential collaboration partners include:

  • Is this an experimental partnership or a long-term plan?
  • What do I bring to the table? How can this partner supplement or support my capabilities?
  • How will this relationship be branded and marketed? Do I need greater visibility than my partner, or will we come together under a new brand?
  • Do we have the IT infrastructure and vendor relationships in place to execute this collaboration? If not, how will secure what we need?
  • Do we have the resources to meet the regulatory requirements of the partnership?
  • How will we measure the success or failure of the collaboration?

Considerations in the RFP Stage

After the initial strategy discussions have taken place, the proposal period raises its own series of considerations. After ensuring that the arrangement proposed can address the goals and objectives of the collaboration, regulatory and transactional issues take center stage. Rights and responsibilities of each party, reporting and compliance mechanisms, fees, credentialing, licensing and privacy compliance and liability issues, to name a few concerns, are addressed at this point in the process. Fees structures and compliance with the evolving federal and state laws regulating telemedicine providers are particularly complex issues that should be addressed at this point.

Questions to address regarding fees include:

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