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Digital Health

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Disruptive digital health technologies have revolutionized the health care industry with innovations spanning applications, portals, tools using biometrics, and devices with Bluetooth connectivity to help increase access to health care.

Why Baker Donelson?

Nearly 200 attorneys and advisors serving the health care sector
Named a Tier 1 firm nationally for Health Care Law by Best Law Firms® in 2024

Practice Overview

Baker Donelson is well positioned to help the health care and technology industries partner to address the growing opportunities of digital health. The Firm's Digital Health Group is a core aspect of Baker Donelson, encompassing 200-plus attorneys and advisors who are dedicated to the health care industry. With practitioners in 11 states and the District of Columbia, Baker Donelson helps clients build upon the upward trajectory of digital health.

We partner with clients to develop and execute digital health strategies by integrating our longstanding experience with disruptive digital technologies and our deep regulatory and public policy experience in the complex business of health care delivery and reimbursement. Those clients are hiring a dedicated, multi-disciplinary team – a team that not only has experience in and detailed knowledge of health law, but also understands the complicated ways in which the industry operates.

The Baker Donelson Digital Health team is unique in its approach. Its nationally ranked Health Care practice includes Health Care Policy, and along with our Health Information Technology; Telehealth; Data Protection, Privacy, and Cybersecurity; Artificial Intelligence; Corporate Finance; Private Equity; Emerging Companies; and Venture Capital practices, provides strategic advice to both start-up clients and established companies.

Our understanding of health care policy, privacy, data protection, and information technology combines to offer our clients a team of attorneys who have represented a variety of players in the digital health ecosystem.

The Firm's Digital Health team assists clients with numerous aspects of digital health, including entity formation and financing, mergers and acquisitions, software and licensing agreements, intellectual property, the viability of a telehealth arrangement, and personnel issues. We also assist clients with Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy requirements and related compliance, as well as incidence responses and health care regulatory compliance. Our strength is in adeptly guiding clients through health corporate transactions, as well as health regulatory issues. This requires a well-versed understanding of the industry and staying abreast of each state's laws and regulations.

We partner with health care providers to help them navigate the many issues that affect digital health. Our clients – from pharmaceutical and medical device companies to investors and software developers – seek legal advisors who are intimately knowledgeable of the ever-changing statutory and regulatory environment.

Addressing the challenges of today's health care environment is no small task, but Baker Donelson's Digital Health team is uniquely prepared to take it on. These challenges include, but are not limited to:

  • Collecting and using data
  • Conducting platform security assessments
  • Managing Anti-Kickback issues, Medicare reimbursement, and enrollment issues associated with structuring telehealth arrangements
  • Assessing and mitigating risk
  • Ensuring regulatory compliance
  • Financing growth and expansion
  • Licensing and collaboration
  • Meeting corporate governance requirements and expectations
  • Addressing litigation and enforcement issues

Proficient in health law, knowledgeable and experienced in health law business and technology, supported by attorneys with a command of the industry's pertinent regulatory issues; able to address the full spectrum of legal needs for technology companies, providers, and investors; capable of ensuring confidentiality, integrity, and availability of health information; and cognizant of the critical health policies being shaped – the goal of the Firm's Digital Health team is to become your trusted advisor and valued counselor.

  • Privacy and Regulatory

  • Represented clients before the Centers for Medicare & Medicaid Services in connection with regulatory and policy interpretation issues and billing revocation determinations; the Office for Civil Rights for HIPAA Privacy Rule investigations and data breach notifications; and the Health Resources and Services Administration, Office of Pharmacy Affairs, for 340B Drug Pricing Program compliance.

  • Co-authored thousands of pages of data security policies and procedures, presented lectures at statewide hospital training conferences and conducted daily help-line services for a hospital association's HIPAA Privacy and Security Compliance Program.

  • Served as lead regulatory attorney advising hospitals in the implementation of electronic health records systems (meaningful use) and the donation of technology to physician groups.

  • Conducted 50-state surveys of state law telehealth laws, regulations, and Medicaid reimbursement requirements.

  • Provided guidance related to licensure, enrollment, and claims submission issues for multi-state telehealth arrangements.

  • Information Technology and Cybersecurity

  • Successfully defended hundreds of financial institutions, health systems, educational institutions, and other businesses in data security breaches and the corresponding federal and state law requirements and investigations; served as regulatory counsel in numerous privacy lawsuits.

  • Served as general counsel to national technology, manufacturing, and professional services firms.

  • Negotiated and closed software and other technology/e-commerce transactions from both the supplier and purchaser perspectives involving software license and service and support agreements, software development agreements, website design and hosting agreements, hardware acquisition and services agreements, and application hosting agreements.

  • Advised the board of a technology business on its $76 million merger transaction with a private equity buyer, including management rollover.

  • Represented a health care IT analytics and services provider in connection with the sale of all of its assets to a large private health IT company in exchange for shares of stock valued at $7 million, plus an earn-out.

  • As counsel to seller – a health IT company – in M&A transaction, handled due diligence matters and negotiation of applicable portions of purchase agreement regarding client's proprietary software, information security posture, and HIPAA compliance.

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