Life Sciences and Healthcare Regulatory

Digital Technologies

Digital technologies are revolutionizing the healthcare industry. From Electronic Health Records (EHRs) that coordinate patient care to mobile applications and Clinical Decision Support (CDS) tools that aid diagnosis, monitor symptoms, and track compliance with medications, healthcare technology is rapidly changing established healthcare delivery models and the rules that govern them. The new model for healthcare requires novel, yet practical approaches to address legal and regulatory issues and research, development, and marketing globalization of such emerging technologies. This model for healthcare delivery will impact cross-border regulations, policies, and best practices in many areas, including regulatory licensing and approval, quality and safety, coverage and reimbursement, market access, healthcare compliance, advertising and promotion, privacy and data security, and litigation and risk management. These issues affect everyone across the care continuum from patients, providers and payors, to developers and regulatory and compliance personnel. Arnold & Porter combines diverse subject-matter experience, deep industry knowledge, international perspectives and innovative problem-solving to help our clients navigate the complex legal and regulatory issues in this thriving and constantly evolving industry.

Representative Matters

  • Providing strategic advice to a global telecommunications company regarding the development, licensing, and marketing of integrated Health IT solutions, software, mHealth, and wireless products.
  • Developed and executed training and compliance programs for business, legal, and regulatory personnel on complaint-handling, advertising and quality systems for mobile applications, and Medical Device Data Systems (MDDS).
  • Advising Fortune 100 Healthcare Company on FDA regulatory requirements for mobile medical apps and Health IT, including premarket and post-market strategy and compliance, device classification issues, labeling, promotion and advertising, and licensing and vendor contracting issues.
  • Providing cross-functional legal support to Health IT company regarding FDA regulatory matters, intellectual property issues, product licensing and transactional matters, privacy and data security protocols for software solutions, and development and implementation of standard operating procedures for promotional review, labeling, licensing, Sunshine Act compliance and management of physician relationships.
  • Providing regulatory counseling and strategic advice to a global pharmaceutical company in connection with the launch of products that combine Health IT, mobile applications, and software tools to provide health management and disease prevention programs for consumers and healthcare providers.
  • Advising wireless medical device manufacturer and Health IT company on Medicare reimbursement and coverage and fraud and abuse issues.
  • Advising remote monitoring, home sleep testing, and diagnostic imaging companies on Medicare reimbursement and coverage matters, teleradiology and telehealth issues, state licensure requirements, and fraud and abuse issues.
  • Providing healthcare regulatory and strategic advice to a medical device company exploring utilization of a telemedicine delivery model for it product.
  • Conducted due diligence for global pharmaceutical company involving acquisition of physician and patient-directed healthcare media and multi-channel marketing platform, including Health IT solutions, mobile apps designed to assist healthcare professionals (HCPs) with management of daily workflow at the point-of-care when they make diagnostic, treatment, and prescribing decisions.
  • Conducted due diligence review for private equity company involving asset purchase of medical device and Health IT solutions for patient diagnosis, electronic healthcare records and financial and operational systems for hospitals.
  • Conducted due diligence for global pharmaceutical company on FDA regulatory issues, Medicare reimbursement and coverage, and fraud and abuse issues involving acquisition of a developer and supplier of remote cardiac monitoring services.



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