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.
Digital Health Services Team
Greenleaf’s team of experts provides guidance to medical device and combination product manufacturers, pharmaceutical and biotechnology companies, trade associations, and other stakeholders implementing and complying with the FDA’s digital health requirements 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:
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:
Success Stories
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.