Telehealth, Mobile Health and Remote Patient Monitoring. Telehealth was created to provide healthcare from a distance. This concept requires digital health companies to know, comply with and implement a patchwork of ever-evolving laws and regulations that differ for each state, payer and country. We help digital health companies keep abreast of these developing compliance requirements.
Our areas of experience include:
- Telehealth and telemedicine
- Medical apps
- Digital clinical trials
- Remote patient monitoring
- Telehealth licensure
- Value-based care
- 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 require a hyper-focus on data privacy and cybersecurity. McGuireWoods’ digital health, technology and innovation group has deep experience in the federal Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act, the EU’s General Data Protection Regulation (GDPR) and American state privacy laws, such as the California Consumer Privacy Act and Illinois Biometric Information Privacy Act.
The group partners with McGuireWoods’ data privacy and security team to advise clients on data breaches, risk assessments, data privacy and security policies, data governance, drafting HIPAA compliance programs, performing employee training, negotiating business associate agreements. We represent clients in interactions with governmental entities, including investigations and audits by the Office for Civil Rights of the Department of Health and Human Services.
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 longstanding contracts that govern these vital systems.
Our areas of focus 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 and data security protections.
Formation, Structuring and Growth. We work with a variety of clients, 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, mergers and acquisitions, private equity investment, 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 experienced in corporate transactions, healthcare and technology. We combine our deep understanding of digital health and technology with McGuireWoods’ powerhouse healthcare private equity and mergers and acquisitions team. We also draw upon the services of the firm’s tax and employee benefits, labor and employment, and intellectual property lawyers, as dictated by a transaction.
McGuireWoods has established itself as a leading law firm for M&A and for private equity transactions. Year over year, McGuireWoods ranks among the top five M&A law firms in reputable, benchmarking league tables published by Bloomberg and Refinitiv. The firm’s M&A practice also has earned nationwide recognition from Chambers USA and The Legal 500. These rankings and recognitions demonstrate McGuireWoods’ commitment to client service and quality counsel, no matter the size or nature of the transaction. Clients count on McGuireWoods to understand their legal challenges and develop innovative strategies to close their deals successfully.
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
- Government investigations
McGuireWoods also assists clients with:
- Litigation and investigations
- Negotiating corporate integrity agreements
- Conducting internal audits to assess regulatory compliance
- Managing responses to government investigations