Practice

Digital Health

Advising you across the health technology spectrum

The expanding innovation in digital health allows providers and patients to harness the power of modern digital technologies to monitor and manage wellness activities, improve health outcomes, and enhance the efficiency of healthcare. Our lawyers leverage their decades of experience in the healthcare, life sciences and technology sectors to effectively guide digital health clients on the regulatory, financial, IP and privacy issues they face in these rapidly evolving environments.

We have a particular focus on digital therapeutics (DTx) and digital diagnostics (DDx), including prescription digital therapeutics (PDTs) and prescription digital diagnostics (PDDs), and are a leader in helping clients navigate the challenges necessary to successfully bring innovative products and therapies to market. 

As digital health continues to evolve, Foley Hoag’s Digital Health Practice is trusted to dispense insights related to all matters facing companies and investors in this space, including complex regulatory, coverage, coding, and reimbursement challenges; financing growth and expansion, intellectual property issues; licensure; protection of data; and federal legislative monitoring and analysis.
 

Areas of Focus

You can trust our insight, as other companies and investors do, in all areas relating to evolving digital health technology, including: 
  • Digital therapeutics
  • Telehealth
  • Remote therapeutic monitoring
  • Wearable devices
  • Virtual and augmented reality
  • Diagnostics
  • Health insurance platforms
  • Artificial intelligence

Experience

We have an impressive track record representing companies of all sizes in digital health matters and transactions:

REGULATORY & REIMBURSEMENT

  • Pear Therapeutics (Nasdaq: PEAR), a pioneer of prescription digital therapeutics, in acquiring a unique HCPCS code, providing a mechanism for medical benefit reimbursement with commercial payers that had not been possible before
  • Drafted legislation introduced in the 117th Congress creating a clear pathway to Medicare and Medicaid coverage for digital therapeutics
  • Advising venture capital firms and digital technology start-ups on pre-market strategy to support successful commercial launches with private and public payers
  • Advised a pharmaceutical manufacturer developing innovative treatment options for individuals with treatment-resistant depression on Medicare and Medicaid coverage, coding and reimbursement matters
  • Assisted multiple digital therapeutic companies on contracts with managed care payers, including Medicare Advantage and Medicaid managed care organizations
  • Drafted comment letters for a HealthTech company on Medicare reimbursement matters and advised that company on CMS proposed changes to Medicare’s benefit category determination process
  • Advised multiple digital health clients on an evolving CMS rule providing expedited coverage for products receiving breakthrough designation from the FDA
  • Assisted clients in the traditional pharma/bio space as well as digital therapeutic space in developing value-based payment arrangements with Medicare and Medicaid, as well as commercial insurers

 

FINANCINGS & OTHER TRANSACTIONS

  • H.I.G. BioHealth Partners and Accelmed Partners as new investors and co-leads in the $52 million upsized Series B financing of digital therapeutics company Click Therapeutics, Inc.
  • Ovuline (d/b/a Ovia Health), a digital health company focused on maternity and family benefits for employers and health plans, in various transactions, including:
    • its sale to leading global life sciences company Labcorp (NYSE: LH) 
    • its $10 million Series A financing
  • Kyruus, a provider search and scheduling company, in its acquisition of HealthSparq from Cambia Health Solutions
  • Healthcare data analytics company Inovalon Holdings (Nasdaq: INOV) in its $1.2 billion acquisition of ABILITY Network, a cloud-based software-as-a-service healthcare technology company
  • Alere Inc. (NYSE: ALR) on the $600 million sale of its Alere Health division to healthcare company Optum
  • Pear Therapeutics in various transactions, including:
    • its SPAC business combination agreement with Thimble Point Acquisition Corp., which valued the combined company at a pro forma equity value of approximately $1.6 billion 
    • its $80 million Series D financing and $20 million Series D extension
    • a $50 million secured loan transaction with Perceptive Advisors
    • its $64 million Series C financing
  • CredSimple, an NCQA certified credentialing and provider data management solution, in its acquisition of Glenridge Health, a technology-enabled provider network management solutions company
  • Quantia, a supplier of social learning and collaboration platforms for physicians, in its sale to Physicians Interactive (a wholly owned subsidiary of Merck), a leading provider of digital engagement solutions for healthcare professionals and consumers

 

LICENSING & COLLABORATIONS

  • LUCID, a developer of digital therapeutics for use in behavioral and neuropsychiatric health, in a collaboration with JT Group for the development of a prescription digital therapeutic for Alzheimer’s disease
  • Digital therapeutic developer MedRhythms in a license agreement with Biogen (Nasdaq: BIIB) to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis
  • AffaMed Therapeutics, a global clinical stage biopharmaceutical company, in its strategic collaboration agreement with leading digital therapeutics company Beijing Infinite Brain Technologies to promote the application and development of digital therapy in neurological disorders
  • Pear Therapeutics in its collaboration with Novartis using Pear’s first ever FDA cleared software application as digital therapeutics in treating schizophrenia and multiple sclerosis

 

PRIVACY AND DATA SECURITY

  • Advising a leader in diabetes-focused virtual care on business structuring, partnering agreements, health information privacy and security matters.
  • A multinational technology and consulting corporation relies on us in numerous patent prosecution services in a variety of technologies including encryption and big data analytics.
  • Provide advice regarding genetic privacy and artificial intelligence applications used to detect physiological patterns that reveal disease-causing genetic variations.
  • Providing advice regarding health information privacy related to use of AR/VR for remote, clinical purposes.

 

News & Insights

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Our attorneys share their points of view on digital health matters.