Chambers USA 2021
Digital Health Legal Solutions
Digital health solutions are fundamentally transforming the quality and delivery of healthcare. As the doctor-patient relationship evolves beyond the in-person encounter, digitized data and technology have converged with healthcare delivery and payment. Our digital health team works with clients to create solutions that improve access to medical services and engage patients in managing their healthcare, with an eye toward the complex and ever-evolving regulatory considerations affecting healthcare innovation.
We offer guidance on all aspects of digital health, including the formation, financing and governance of business entities, joint venture arrangements, and mergers and acquisitions. Drawing on our vast institutional knowledge and the creativity to drive forward-looking solutions, we counsel clients in a wide range of areas, including development, reseller marketing and distribution arrangements, intellectual property protection and licensing agreements, systems integration agreements, internet and new technology issues, product liability matters, and employment and noncompetition agreements, as well as related personnel issues.
Our team leads emerging and established organizations through the unique—and often unanticipated—transactional, regulatory and compliance challenges they face. Uniting our depth of experience and our ability to anticipate change, we help clients develop creative solutions to the obstacles that slow adoption and growth so they can keep moving forward in an ever-changing industry.
How can we help you transform healthcare?
- Health Information Technology
- Mobile Health
- Big Data and Data Strategies
- Data Privacy/Security HIPAA and State Laws
Health Information Technology
Complex legal and compliance issues surround the acquisition, implementation, use and management of health information technology (HIT). Our team offers advice on key matters in a quickly changing landscape, including patient consent issues involved with health information exchanges; electronic communication issues among and between providers, payers and patients; and matters involving electronic health records (EHRs), health information exchanges (HIEs), and the use and disclosure of protected health information (PHI). We also counsel our clients on compliance with the Health Insurance Portability and Accountability Act, state breach notification laws, Medicare and Medicaid EHR Incentive Program requirements, the False Claims Act, the Anti-Kickback Statute, and other federal and state healthcare regulatory laws.
For clients ranging from physicians, hospitals and health systems to practice management companies, HIT vendors and medical billing companies, we offer skillful support with software and hardware procurement, implementation, service level agreements and warranties, and associated contract and regulatory compliance aspects.
Mobile healthcare devices, including wearables and medical apps, empower patients to better understand their health. These devices capture consumer-generated health data, analyze it and provide mobile feedback to consumers. These mHealth applications may also deliver healthcare information to providers and researchers in order to facilitate efficient coordination of care. Our team assists clients with the transactional and regulatory issues that arise when businesses engage with patients, consumers, providers or researchers about their health needs, whether through mobile devices or other connected devices outside of traditional healthcare provider settings. We also offer counsel on issues arising from emerging digital health tools, such as mobile medical apps, that the US Food and Drug Administration (FDA) may consider regulated devices.
Big Data and Data Strategies
We assist clients with the design and deployment of big data strategies. Supported by a flexible, yet sustainable, privacy and security protection infrastructure, big data strategies can capture, aggregate, transform and analyze key data. Businesses use these sophisticated analytics to effectively implement improvements in healthcare quality, coordination, accessibility and affordability for the benefit of payers, employers and healthcare consumers. Our team helps identify, manage and resolve legal issues associated with high-volume analytics and data mapping, privacy and security protections, data licensing and clinical research activities, including federal and privately sourced data. We also assist in forging collaborations between industry stakeholders to leverage strengths and accelerate initiatives.
Data Privacy/Security HIPAA and State Laws
The Health Insurance Portability and Accountability Act (HIPAA) governs the use and disclosure of identifiable health information. Using our industry-leading best practices, we counsel a diverse range of clients in navigating these complex rules. We conduct audits, develop customized plans, policies and procedures for privacy and security compliance, and even facilitate HIPAA-related training sessions.
If a crisis does arise, we also advise clients regarding security breaches, risk assessment, mitigation and remediation, and negotiate settlements and resolution agreements with the US Department of Health and Human Services Office for Civil Rights. Together with lawyers in our privacy and data protection practice, our digital health team has guided companies through the successful resolution of many privacy and security incidents, including hundreds of incident responses and breach remediation efforts involving PHI. From cyber attacks and malicious insiders, to lost laptops, unsecured data and mailing mishaps, we have handled the full spectrum of information incidents.
We draw on this experience to bring calm to the storm and provide guidance from beginning to end, including developing and implementing effective audits, protection and loss-prevention programs, and simplifying the notification process across jurisdictions.
Bringing the doctor-patient relationship out of the confines of an in-person encounter, telehealth integrates information technology with traditional healthcare and wellness practices. Remote healthcare, also called telemedicine, is changing the way medical services are delivered. Thanks to advances in technology and information systems, these new diagnostic tools and methodologies can improve access to and consistency of medical services—an important benefit to consumers and providers alike. Our clients turn to us for guidance regarding licensure, patient consent and recordkeeping, data privacy, risk mitigation, and navigating the varied state-based regulations and regulatory definitions associated with telehealth. We help assess business strategies and advise on government and commercial reimbursement standards so clients can succeed in this rapidly changing, highly regulated industry.