Helping Healthcare Navigate the Digital World
Manatt works with the entire array of healthcare industry organizations to help them achieve their strategic goals at the intersection of health and technology. Manatt’s interdisciplinary team provides a full range of business advisory services, policy and regulatory support, and legal guidance across the entire digital health landscape.
Our digital health team serves its clients from a broad and deep base of experience as entrepreneurs, regulators, venture investors, technologists, provider and payor leaders, and life sciences professionals. We work closely with leading digital health innovators, venture and private equity investors, healthcare providers, payors, technology companies, medical device manufacturers, life sciences companies, governments, and not-for-profit organizations to deliver creative results that drive growth in an ever-changing environment. We have particularly deep experience in telehealth and virtual care, tech-enabled services, digital therapeutics and digital medicine, artificial intelligence, Medicaid, Medicare Advantage, and other rapidly evolving areas of digital health.
- FDA Regulatory Strategy and Compliance—Our seasoned team helps developers of innovative digital health solutions determine whether their products are regulated by the Food and Drug Administration and guides them through the regulatory maze to bring their products to market. From rapidly changing FDA digital health policies to clinical evidence strategies and navigating regulatory issues for AI and machine learning products, we help companies understand the landscape and develop strategies to achieve their business objectives. Leveraging our unique integrated model, we bring together legal and strategic business problem solving not just to obtain marketing authorization but also to succeed in the marketplace.
- Business Model, Pricing, and Reimbursement and Product Strategy—We provide strategic advice on business model design, pricing and reimbursement strategy, and we support product conceptualization, design and market testing to drive rapid growth for digital health businesses, products and services. We advise companies ranging from startups to growth-stage companies to established life sciences and medtech companies.
- Digital Transformation, Digital Health Adoption and Organizational Design—Manatt has deep experience in assisting healthcare providers, payors and life sciences companies in designing and executing their digital transformation and digital health strategies, including optimizing how digital and technology programs can best support their overall enterprises. We regularly advise the nation’s top health systems, payors and life sciences companies on issues related to digital health, virtual care, telehealth and remote patient monitoring, as well as help these organizations navigate the complex and ever-evolving regulatory and reimbursement environment related to digital health. We also design optimal and highly customized organizational structures, as well as models for roles and responsibilities, reporting relationships and resource sharing, and collaboration, that enable complex organizations to achieve their overall digital objectives.
- Telehealth Policy Design and Implementation—Manatt closely tracks the rapidly evolving federal and state telehealth and digital health policy landscape. We are frequently called upon by state governments and Medicaid programs, payors, foundations and provider organizations to interpret complex regulatory and policy topics, design and implement innovative policies, and identify areas of opportunity to thoughtfully expand access to digital health technologies while reducing the risk of fraud.
- Privacy, Data Security and Data Governance—Manatt’s multidisciplinary and global privacy and data security practice provides critical services at the intersection of corporate data and legal and operational risk. Our end-to-end practice spans the spectrum of cybersecurity services, including proactive counseling, assessment, program development, incident preparedness and reactive incident response, regulatory inquiries and investigations, and litigation defense. We have counseled clients on some of the most significant and complex public and nonpublic data security incidents and privacy matters, both domestically and abroad, and on related litigation and regulatory investigations.
- Full Range of Corporate, Regulatory and Transactional Legal Capabilities—We provide the full continuum of legal services related to digital health, leveraging our deep experience in health technology, delivery system transformation, regulatory restrictions and payment models. Our capabilities include corporate structuring, intellectual property, investment, partnership, M&A support, regulatory, litigation and other legal services needed to operate in the ever-evolving digital world. We also offer pre-transaction and transaction strategies and support for deal structuring and negotiations to position clients for the right targets and outcomes.
- Innovation and Investment Program Advisory Services—We work with leading institutions at all stages of their innovation and commercialization program development and operations. Our team can assess a client’s overall commercialization and innovation programs, teams and results in order to identify ways to elevate the impact and financial return of intellectual property assets and pipelines and how to introduce external innovations to the core operations. We also support a wide range of healthcare industry stakeholders in designing and operationalizing their partnership and investment programs, including assisting with venture fund models, investment strategies and deal sourcing. Our legal team regularly advises a range of clients from large Fortune 500 companies to emerging health tech innovators on how to optimize the business structures and partnership engagements that evolve from these programs.
- U.S. Market Entry and Partnership Formation for Non-U.S. Companies—Manatt supports international clients in navigating the complex healthcare business and regulatory landscape they face when entering the U.S. market, including educating them about how the market operates, market entry and distribution channel strategy, and how to understand and navigate the U.S. regulatory and reimbursement landscape. Clients trust Manatt as a highly diversified partner that can help them understand the U.S. healthcare market from all angles, enabling them to optimize for launch and scale and minimize false starts.
We successfully assisted the following companies:
FDA Regulatory Strategy and Compliance
- Fitbit in obtaining 510(k) clearance for a smartwatch-based atrial fibrillation detection application.
- CuraCloud in obtaining 510(k) clearance for CuraRad-ICH, an AI-based CT-imaging triage software for intracranial hemorrhage.
- Caption Health (formerly Bay Labs) in obtaining De Novo marketing authorization for the innovative Caption Guidance, which uses artificial intelligence to provide real-time guidance and diagnostic quality assessment during acquisition of echocardiography, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Also in seeking 510(k) clearance for its EchoMD AutoEF software, which applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.
- Eko in obtaining 510(k) clearance for a suite of machine learning and signal processing algorithms designed to provide clinical decision support to physicians during the evaluation of cardiac data, and in obtaining Breakthrough Device designation for a novel ECG-based algorithm.
- IDx LLC in obtaining De Novo reclassification from the FDA for the groundbreaking AI-based IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.
- Biobeat in obtaining 510(k) clearance for the company’s noninvasive multiparameter wearable sensor (pulse rate, blood oxygen saturation and changes in blood pressure).
- Exact Sciences in obtaining FDA approval for Cologuard, the first noninvasive sDNA screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.
Business Model, Market Entry, Product Strategy and Reimbursement Strategy
- 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 healthcare 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 healthcare 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.
Digital Transformation, Digital Health Adoption and Organizational Design
- 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.
Telehealth Policy Design and Implementation
- 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.
Privacy, Data Security and Data Governance
- A women’s healthcare digital health and brick and mortar company with coming into compliance with HIPAA, first as solely a technology company and then as a healthcare 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.
Full Range of Corporate, Regulatory and Transactional Legal Capabilities
- 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 healthcare-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 healthcare system with drafting and negotiating a value-based-payment arrangement with Medicaid managed care plans.
Innovation and Investment Program Advisory
- 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 healthcare foundation with completing an internal and external review of a digital health venture capital fund and investment strategy.
U.S. Market Entry and Partnership Formation for Non-U.S. Companies
- 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 healthcare 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 healthcare 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.