Digital Health Services

The increasing adoption and use of digital health technologies, including wearable devices, mobile applications, software as a medical device (SaMD), and artificial intelligence (AI) programs, have opened new and innovative ways to improve patient health and health care delivery. Digital health technologies are driving a major evolution in drug and medical device development, empowering patients to make better-informed decisions while managing their own health and wellness, and allowing health care providers to care for patients with greater effectiveness and efficiency.

Players in the digital health space face unique challenges in navigating an ever-changing regulatory landscape, as Food and Drug Administration (FDA) regulators try to keep up with the pace of digital health technology development. Greenleaf Health serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies.

Our Digital Health Services

Areas of Expertise

Greenleaf’s digital health clients vary greatly in nature, scope, and levels of experience with FDA regulation. Because there is no one-size-fits-all approach, each solution is built to fit the targeted needs of the client. Greenleaf regularly provides expertise to the following types of clients:

  • Start-up and mid-size software companies developing digital health mobile apps
  • Drug companies entering the digital health space to enhance the patient or health care provider experience of their products
  • Diagnostic testing companies developing applications to read diagnostic test results
  • Consumer product companies entering the digital health space with limited FDA regulatory experience
  • Investors identifying and evaluating regulatory risks in potential digital health investments
  • Trade associations and global drug and medical device companies developing digital health policy strategies
  • Artificial intelligence (AI) program developers seeking FDA regulatory insight and clarity
  • Telehealth companies partnering with clinical practitioners and life science companies to offer online access to medical products
  • Health policy and research organizations developing, tracking, and responding to digital health policies, legislation, and initiatives
  • Drug and device companies using digital tools to conduct decentralized clinical trials

Strategic & Technical Guidance

The combined knowledge and substantial qualifications of the Greenleaf team ensure best-in-class insight for companies navigating digital health regulations. Greenleaf offers the following digital health-focused services:

Provide insight, clarity, and strategic consultation on digital health topics

  • Advise clients on FDA regulatory policies, programs, and procedures, including questions related to jurisdiction to regulate, device classification, and potential pathways to market 
  • Partner with clients to design strategies for product development and premarket review
  • Assist with marketing application preparation and submission
  • Provide advice regarding FDA communications, including compliance and regulatory correspondence
  • Advise on FDA labeling and postmarket safety requirements

Assist entities involved in digital health technology investments and transactions

  • Perform due diligence and regulatory risk assessments of potential targets
  • Advise investors on opportunities to manage and mitigate risks in order to achieve desired regulatory outcomes
  • Research and analyze regulatory data sources

Help clients keep pace with developments and navigate the emerging regulatory landscape

  • Identify novel regulatory tools and approaches to optimize the development process
  • Support clients in structuring their regulatory policy capabilities to effectively advance priorities
  • Design and implement strategies that engage stakeholders, leverage alliances, and advance regulatory policy

Full-Service Support

Greenleaf professionals work as teams specializing in medical devices and combination products; product quality, manufacturing, and compliance; and drug and biological products. Greenleaf’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges. Greenleaf’s collaborative services include:

Greenleaf guides clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems.

Greenleaf supports clients maneuvering the sophisticated process of bringing new therapeutics to market. Experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements.

Greenleaf provides expertise to companies seeking to strengthen their quality management systems. Experts specialize in corporate quality and compliance systems; FDA inspections, communication, and enforcement processes; and the complete spectrum of compliance and enforcement-related actions.

Success Stories

  • Helping a Digital Therapeutic Client Successfully Navigate the De Novo Regulatory Pathway

    Greenleaf Health helped a digital therapeutic company developing cognitive treatments as it navigated the de novo classification request regulatory pathway. Greenleaf experts worked closely with the client to address FDA concerns and requests regarding the digital therapeutic device, helping to clarify the FDA’s questions and recommendations and assisting with drafting written correspondence to the Agency. With Greenleaf’s …

  • Identifying a Direct Path to Market for a Wellness Software Product

    Greenleaf Health provided strategic and tactical advice to an early-stage software as a service (SaaS) start-up developing and commercializing a software product intended for mental health providers and patients. The Greenleaf team reviewed various proposed claims for the client’s product to ensure that the claims would not cause the software to be an FDA-regulated medical …

Digital Health Services Resources

View or download the PDFs below to learn more about Greenleaf’s digital health services and our comprehensive regulatory consulting capabilities.

Connect With an Expert

Greenleaf’s Digital Health Services Team is ready to support your company’s digital health program. Please provide the information below and a team member will be in contact.

Connect with an Expert - Digital Health Services