Overview
Technology has transformed every aspect of health care. From digitized records to diagnostics powered by artificial intelligence (AI) to innovations in telehealth and remote care, opportunities are everywhere for emerging and established companies alike.
At the crossroads of health strategy, technology and law, Manatt offers a unique, fully integrated model that combines legal, policy and business consulting services. Our interdisciplinary team helps clients—including health systems, health tech companies, government agencies, payers, pharma and medical device companies, investors, and associations and foundations —navigate complex challenges and accelerate innovation across the digital health landscape.
Our approach is driven by real-world experience as entrepreneurs, operators, regulators, investors and industry executives. Whether you’re embarking on a digital transformation, launching a new product, scaling operations or structuring a strategic partnership, we deliver actionable guidance aligned with your business goals.
Manatt advises on all aspects of digital health, including go-to-market strategy, pricing and reimbursement, Food and Drug Administration (FDA) strategy and compliance, Medicare and Medicaid entry and product development. We have particular expertise in AI, telehealth, remote monitoring, digital therapeutics and tech-enabled services.
To help our clients stay current on policy developments related to telehealth and related digital efforts, we have created the .
Areas of focus
- Business model, pricing and reimbursement and product strategy
- Go to market strategy and execution support
- Corporate, regulatory and transactional legal capabilities
- Digital transformation, digital health adoption and organizational design
- FDA strategy, advocacy and compliance
- Innovation and investment program advisory services
- Health technology and AI policy design and implementation
- Privacy, data security and data governance
- U.S. market entry and partnership
We offer comprehensive legal services for health tech ventures—from corporate formation and financing to M&A, regulatory compliance and litigation. Our team also supports innovation program design, venture fund structuring and commercialization strategies to help clients maximize ROI and market impact.
With a 360-degree view of the digital health ecosystem, Manatt is a trusted partner to innovators, investors, hospitals and health systems and public institutions seeking to shape the future of health care.
Areas of focus
- Business model development
- Contracting models, including, value-based arrangements and joint ventures
- Compliance, fraud and abuse advising
- Corporate and transactions support
- FDA strategy
- Go-to-market strategy
- Medicaid market entry
- Policy and regulatory support
- Privacy and data security
- Scaling operations
As health organizations deploy AI and advanced analytics, Manatt offers guidance on governance frameworks, contracting, policy tracking and lobbying, intellectual property considerations and privacy and data security.
To help our clients monitor federal and state policy developments related to AI, we offer our , updated quarterly.
Areas of focus
- AI legislative, regulation and policy tracking
- AI governance and oversight
- Commercialization
- Contracting
- Coverage and reimbursement
- Intellectual property
- Privacy and security
Experience
We successfully assisted the following companies:
- A leader in health technology for movement disorders with developing a new product market entry strategy, including its go-to-market approach, channel strategy and pricing model.
- A digital health spin-out of a major medical device company with advisory services regarding product features, product/market fit, pricing and partnership strategy.
- A top-five cancer hospital with advisory services on the development of a hospital-at-home program, with a focus on addressing regulatory hurdles and implementing the model with commercial payors during the COVID-19 pandemic and beyond.
- A leading digital behavioral health company with supporting the development of the company’s health care market entry strategy by surveying potential purchasers regarding potential product offerings, providing case studies of similar products/services, analyzing reimbursement issues, and providing recommendations on which strategies would put the company on the fastest route to revenue growth.
- A top global pharma/life sciences company with developing detailed landscape analyses, a competitive assessment, partnership options and business model concepts in several therapeutic areas that formed the basis for a digital health strategy.
- A leading home-based diagnostic testing company with conducting health care market entry research and analytical support including internal and customer interviews, external market research, prospect targeting, and digital health data strategy recommendations.
- One of the largest health plans in the Southeast with crafting a strategy for service offerings for an unserved market by conducting a market landscape assessment and user-centered design research to develop a build/buy/partner framework and go-to-market strategy.
- A top-five children’s hospital with supporting the execution of the hospital’s digital health strategic plan by playing an operational role in the implementation of several “quick win” digital health initiatives and developing a detailed telehealth strategy.
- A top-five teaching hospital in the Northeast with developing a telehealth strategic growth plan, including defining future-state programmatic priorities, developing an implementation and operating model, conducting an ROI analysis, and developing a 12-month implementation roadmap.
- A leading academic health system in the Southeast with developing a three-year telehealth strategic plan including a telehealth operating model and implementation roadmap. For the same client, we developed a tele-stroke strategy for a series of joint-venture-owned hospitals and facilitated a vendor selection process for the identification of a direct-to-consumer telehealth services vendor.
- A leading not-for-profit private health system in the Tri-State area with developing a systemwide digital transformation strategy that included a gap analysis of the system’s existing digital health capabilities, prioritization of digital health projects based on the system’s strategic objectives, future-state organization and governance recommendations, and step-by-step implementation roadmaps for high-priority digital health priority projects.
- A leading academic health system in the Northwest with developing a three-year digital health strategy including designing a systemwide governance and operating model, identifying near- and long-term programmatic priorities, developing an implementation approach and structure, and crafting a detailed 18-month implementation plan.
- A midsize global pharma company with digital health organizational and data strategy and program design.
- A state Medicaid program in the Southeast, supporting the development of new temporary telehealth coverage and payment policy in response to the COVID-19 pandemic and the development of a new permanent comprehensive telehealth coverage and payment policy for when the pandemic ends.
- A state Medicaid program in the Mid-Atlantic with reviewing pre-COVID-19 telehealth coverage and payment policies and proposed policy revisions to enable greater access to telehealth during the pandemic, including providing service-specific analyses and recommendations to inform the development of the Medicaid program’s post-pandemic telehealth policy.
- A multinational biopharmaceutical company with monitoring and providing regular updates on the rapidly changing federal- and state-level telehealth policy landscape, changes to telehealth coverage by major commercial payors, and relevant reports and studies regarding telehealth.
- A women’s health care digital health and brick and mortar company with coming into compliance with HIPAA, first as solely a technology company and then as a health care provider, which involved developing HIPAA policies and procedures, workflows, and consumer-facing materials. We also assisted the company with building a compliance program for nonmedical privacy laws and regulations, including the CCPA.
- A dental benefits third-party administrator with supporting all elements of its data privacy and security needs, including development of business associate agreements; review of contracts that involve sharing or receiving protected data, including PHI; and investigating and responding to breaches that may trigger reporting under HIPAA and state privacy laws.
- An AI-enabled diagnostic and analysis company with performing a HIPAA and CCPA compliance readiness assessment and proposing remediation strategies.
- Multiplatform maternity care company with compliance with non-health privacy laws and regulations.
- A data-driven care management company with corporate formation and related regulatory questions and providing general business strategy advice related to business models, partnerships and partnership models, and fundraising strategies.
- A blood function diagnostics company, providing corporate structuring, general business advisory, fundraising readiness and venture capital transaction support.
- A leading digital behavioral health company, providing health care-specific corporate structuring advice related to corporate practice of medicine and licensure considerations, as well as health plan contracting strategies.
- A digital health platform connecting patients to mental health providers, drafting contracts with payors and providers; analyzing whether arrangements implicate fraud and abuse laws, such as the Anti-Kickback Statute or Stark Law; and assessing the provision of patient incentive programs to ensure compliance with the Civil Monetary Penalties Law.
- A tech company connecting school nurses to the health care system with drafting and negotiating a value-based-payment arrangement with Medicaid managed care plans.
- A top-five children’s hospital with the development of an innovation and commercialization strategy by developing a consistently usable, structured and predictable framework and process for identifying, evaluating, developing and commercializing scientific breakthroughs, including specific decision points for when and how to move and finance innovations through spin-outs.
- A health tech and services private equity fund with developing the fund’s investment strategy and thesis, developing the fundraising prospectus, and providing ongoing support for identifying potential investments.
- A leading social innovation lab in developing a venture capital investment strategy.
- A leading health care foundation with completing an internal and external review of a digital health venture capital fund and investment strategy.
- A leading Australian telehealth company with developing a U.S. market entry strategy, including an analysis of ideal launch markets, a product market fit analysis, and a pricing and partnership strategy.
- A medication adherence tech company with developing a U.S. market entry strategy that included recommendations about how to optimize the company’s offering for the U.S. market and provided corporate health care counsel to ensure its success in consummating a key U.S. company partnership.
- An Australian media company with analyzing the risks and liability associated with becoming a HIPAA business associate to health care providers in the U.S. and preparing a memorandum upon which the board of directors relied in making its determination to enter the U.S. market.
Related Practices
Artificial Intelligence
Government and Regulatory
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