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At Jones Walker, our Healthcare Industry Team is excited about the endless opportunities digital healthcare can provide for physical and mental health and well-being in Louisiana.
Digital healthcare has rapidly moved from the margins into the mainstream of the American healthcare system, accelerated by COVID-19 and ongoing regulatory flexibility. It covers telehealth, mobile apps, electronic records, remote monitoring, and the broader Internet of Medical Things (IoMT). Together, these tools improve patient access, enhance provider decision-making, and generate data-driven insights.
Adoption and Benefits
Telehealth is now a permanent fixture in many care settings, with Medicare and states extending coverage for behavioral health, primary care, and specialty consults. Mobile health apps and wearables support patient engagement, while remote monitoring tools help detect conditions early and reduce hospitalizations. Electronic health records and decision-support systems streamline operations, cut costs, and improve care coordination. For patients, the benefits include convenience, reduced wait times, and more personalized care. For health systems and insurers, digital healthcare offers efficiency gains and cost savings through early intervention and automation.
Legal Framework
Unlike traditional healthcare, digital health lacks a single, unified definition in the American legal system. Instead, it is regulated by a patchwork of federal and state frameworks.
- Privacy and security: The Health Insurance Portability and Accountability Act (HIPAA) and The Health Information Technology for Economic and Clinical Health (HITECH) Act govern health information for covered entities, but gaps remain for consumer apps and wearables. State laws like The California Consumer Privacy Act (CCPA) and Washington's My Health, My Data Act increasingly fill these gaps.
- Medical devices/software: The Food and Drug Administration (FDA) regulates software as a medical device (SaMD) and has created a Digital Health Center of Excellence. The 21st Century Cures Act excludes certain low-risk apps from regulation.
- Telehealth: State licensing rules, the Interstate Medical Licensure Compact, and federal Medicare telehealth provisions shape access. Many COVID-era flexibilities remain in place through September 2025.
- Artificial Intelligence (AI) and emerging technologies: The FDA, The Department of Health and Human Services (HHS), and Congress are developing new oversight for AI-enabled tools. Over 45 states have introduced AI bills since 2023.
- Cybersecurity: Recent laws now require connected medical devices to address security vulnerabilities in pre-market submissions.
Oversight and Enforcement
Regulation is shared among numerous federal and state bodies. HHS oversees HIPAA and privacy, the FDA regulates medical devices, The Centers for Medicare and Medicaid Services (CMS) sets reimbursement policy, and the Federal Trade Commission (FTC) monitors advertising and non-HIPAA privacy practices. The Department of Justice (DOJ) and state attorneys general pursue fraud and consumer protection violations, while state licensing boards oversee provider conduct. Enforcement actions range from HIPAA breach penalties and device recalls to telehealth fraud prosecutions.
Liability Risks
Digital health companies and providers face overlapping risks: HIPAA violations, unapproved device claims, cross-border licensing infractions, deceptive advertising, billing fraud, malpractice in telemedicine, product liability for faulty software or devices, and cybersecurity negligence. Liability often spans multiple parties—providers, platforms, health systems, and software developers—raising complex questions about responsibility, especially when AI influences medical decisions.
Emerging Issues and Reform
Key trends include permanent telehealth expansion, broader state and federal privacy protections, mandatory interoperability standards (FHIR APIs), cybersecurity enhancements, and frameworks for AI-enabled medical devices. Policymakers are experimenting with "regulatory sandboxes" and public-private partnerships to keep pace with innovation. The challenge ahead is balancing innovation and investment opportunities with patient safety, privacy, and trust.
Louisiana's healthcare system is poised for a new era of growth with digital transformation, and we are proud to lead the way forward for Louisiana healthcare providers and support companies as they navigate this evolving and complex legal and regulatory environment.
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