Digital health encompasses an ever-growing convergence of digitized data and digital solutions with health care delivery and payment, and is fundamentally transforming health care delivery, health care quality and innovation. As the doctor-patient relationship evolves beyond the in-person encounter, McDermott’s focused digital health teams work with our clients to develop and implement technologies that can improve access to medical services and engage patients in the management of their health while also meeting complex—and still evolving—regulatory considerations.
Drawing on our in-depth understanding of today’s rapidly evolving digital health environment, we counsel clients on the changing dimensions of health information technology (HIT), telemedicine, mHealth (mobile health), big data and data strategies, data privacy and security as they relate to HIPAA and state laws.
We understand all aspects of digital health, including its involvement and impact on today’s health care industry. We offer legal guidance on the formation, financing and governance of business entities, joint venture arrangements, and mergers and acquisitions. In addition, we support our clients in all aspects of 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 and related personnel issues.
Our digital health lawyers operate at the cutting edge of developing health care technologies. Uniting our depth of experience in health care transactions and regulation, the flexibility and responsiveness of our practice, and our commitment to anticipating changing health care needs, we help clients achieve their patient-care, operational and financial goals.
We advise on the complex legal and compliance issues relating to the acquisition, implementation, use and management of health information technology (HIT). Our clients range from physicians, hospitals and health systems to practice management companies, HIT vendors and medical billing companies. Our team assists with software and hardware procurement, implementation, service level agreements and warranties, and associated contract and regulatory compliance aspects such as meaningful use attestation and PQRS quality measure reporting. We also counsel clients on patient consent issues involved with health information exchanges (HIEs), electronic communication issues among and between providers, payers and patients, and matters involving electronic health records (EHRs), HIEs, and the use and disclosure of protected health information (PHI). Our clients also rely on our advice to ensure compliance with HIPAA, state breach notification laws, Medicare and Medicaid EHR Incentive Program requirements, the False Claims Act, the Anti-Kickback Statute, and other federal and state health care regulatory laws.
As consumer-facing technology empowers patients to better understand their personal health, mobile health care devices, including wearables and medical apps, have moved into the mainstream. Such mobile devices capture consumer-generated health data that is analyzed with the assistance of big-data analytics platforms, and provide feedback to consumers on a mobile basis. mHealth applications also deliver health care information and analysis to providers and researchers to facilitate efficient coordination of care and reduce duplication of effort. We assist clients with the transactional and regulatory issues that arise when businesses engage with patients, other consumers, providers and/or researchers about their health needs, issues and status, whether through mobile devices or other connected devices outside of traditional health care provider settings. Clients also turn to us for counsel on issues arising from innovative, emerging digital health tools (such as mobile medical apps), many of which may be considered by the FDA as regulated devices.
Businesses rely on sophisticated analytics to respond effectively to intense pressures from payers, employers and health care consumers for improvements in health care quality, coordination, accessibility and affordability. We assist clients with the design and deployment of big-data strategies, supported by a flexible and yet sustainable privacy and security protection infrastructure, to capture, aggregate, transform and analyze key data. We also assist in forging collaborations with other industry stakeholders to leverage one another’s strengths and accelerate their big-data initiatives. We help providers, payers, HIT vendors and other stakeholders identify, manage and resolve legal issues associated with high-volume analytics and data mapping, privacy and security protections, data licensing, and clinical research activities that include federal and privately sourced data.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) governs the use and disclosure of an individual’s identifiable health information. Using our industry-leading best practices, we help a diverse range of clients navigate these complex HIPAA rules. We regularly conduct privacy audits, develop customized compliance plans, policies, procedures and forms for privacy and security compliance, and deliver training sessions on HIPAA-related issues. We advise clients on a daily basis in connection with security breaches, risk assessment, risk mitigation and remediation, and regularly negotiate settlements and resolution agreements with the US Department of Health and Human Services Office for Civil Rights.
Together with lawyers in our Privacy & Data Protection practice, our digital health team has guided companies through the successful resolution of countless privacy and security incidents, including hundreds of incident responses and breach remediation efforts involving PHI. From cyberattacks and malicious insiders to lost laptops, unsecured data and mailing mishaps, we have handled the full spectrum of incidents. Clients routinely praise us for being “the calm in the center of the crisis storm.” We draw on this experience to provide end-to-end guidance, from developing and implementing effective audit, protection and loss-prevention programs, to simplifying the notification process across jurisdictions (a process that can often require coordination with numerous states, territories and international jurisdictions).
Telemedicine, or the remote provision of health care, is changing the way medical services are delivered. Telehealth integrates information technology with traditional health care and wellness practices, and means that the doctor-patient relationship is no longer confined to the in-person encounter. Advances in technology and information systems have supported the creation of diagnostic tools and methodologies that can improve access to and consistency of medical services—an important benefit to consumers and providers alike. McDermott’s digital health lawyers help clients navigate the varied state-based regulations and regulatory definitions associated with removing the in-person encounter from health care delivery. We help assess business strategies and advise on government and commercial reimbursement standards. Our clients turn to us for guidance regarding licensure, patient consent and recordkeeping, data privacy, and risk mitigation, helping them take advantage of this rapidly changing and highly regulated industry.