Digital Health, Technology and Innovation

Healthcare innovation is creating new investment, research and development opportunities in digital health and health information technology. McGuireWoods’ Digital Health, Technology and Innovation Group helps clients navigate transactional, regulatory and compliance challenges. Our group sits at the intersection of healthcare and technology. We are part of McGuireWoods’ more than 60 healthcare attorneys and more than 45 data privacy and security attorneys located in jurisdictions throughout the world.

Telehealth, Mobile Health and Remote Patient Monitoring. Telehealth was created to provide healthcare from a distance. This concept inherently requires digital health companies to know, comply and implement a patchwork of ever-evolving laws and regulations that are different for each state, payer and country. We help digital health companies keep abreast of these evolving compliance requirements.

Our areas of expertise include:

  • Telehealth and telemedicine
  • Medical apps
  • Wearables
  • Digital clinical trials
  • Remote patient monitoring
  • Telehealth licensure
  • Medical malpractice insurance
  • Patient consent
  • Physician-patient relationships
  • Online prescribing
  • Corporate practice of medicine
  • Medicare, Medicaid and private payer reimbursement

Data Privacy and Security. Digital health and health information technology requires a hyper-focus on data privacy and cybersecurity. McGuireWoods’ Digital Health, Technology and Innovation Group has deep expertise in HIPAA, HITECH, GDPR and state privacy laws. We help clients with data breaches, risk assessments, data privacy and security policies, and data governance. Our group partners with McGuireWoods’ Data Privacy and Security Team to advise clients on all aspects of data privacy and cybersecurity. 

Health Information Technology. Information technology is crucial to delivering healthcare services today. To avoid costly mistakes, healthcare providers must properly negotiate the high-value and long-standing contracts that govern these critical systems, such as electronic medical record agreements, revenue cycle management agreements, and licensed software service agreements.

Our areas of expertise include:

  • Electronic medical record agreements (EMR and EHR)
  • Revenue cycle management agreements
  • Software as a service (SaaS) licensing agreements
  • Vendor and supplier agreements
  • Healthcare IT regulatory compliance, such as information blocking

Big Data and Data Strategies. Information technology requires strategies that can transform and aggregate data. We assist clients in managing and identifying issues involved with data analytics, data mapping, data licensing, clinical research activities and data security protections. Our team also is skilled in developing collaborations between health technology stakeholders.

Formation, Structuring and Growth. We work with clients across the spectrum from early-stage digital health startups to the most sophisticated international digital health companies. We meet clients where they are, whether formation, corporate practice of medicine structuring, IP protection, venture capital or international complexities.

Mergers and Acquisitions. Purchasing or selling a digital health business is a significant decision that requires an interdisciplinary legal team in healthcare and technology. We combine our deep understanding of digital health and technology with McGuireWoods’ powerhouse Healthcare Private Equity and Mergers and Acquisitions Department. We also draw upon the services of the firm’s tax and employee benefits, labor and employment, and intellectual property, as dictated by a transaction.

Fraud and Abuse. Like traditional healthcare companies, digital health and technology companies are subject to healthcare fraud and abuse laws. These laws govern relationships between providers, physicians and referral sources, and regulate compliance with third-party payer billing requirements.

We advise companies on:

  • The Stark law
  • The Anti-Kickback statute
  • Fee-splitting
  • Corporate practice of medicine
  • False claims
  • Overpayments
  • Government investigations

Clinically Integrated Networks. Our team advises clients on clinical integration, population health management and care coordination strategies that align with health technology. We have experience developing and structuring CINs, ACOs, PHOs and IPAs. Our experience includes advice on varied reimbursement methodologies, such as shared savings, bundled payments, pay-for-performance and multiple risk pools. Our team also provides antitrust and clinical integration reviews so that all arrangements are analyzed within a regulatory framework that meets the client’s objectives.

Patient Safety Organizations (PSOs). The Patient Safety Act allows providers to report safety and quality data in a protected environment that offers privilege and confidentiality protections. PSOs enable providers to improve performance, value and clinical integration. Our team advises clients on structuring and implementing a PSO for their own organization or creating a PSO as part of a clinically integrated network. We also help clients contract with PSOs and review data privilege and peer review issues associated with patient safety reporting.

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