Welcome to our blog, your go-to resource for the latest insights and trends in the life sciences industry.
Our blog is designed to provide expert guidance, practical tips, and thought leadership on key areas like medical device development, digital health, and clinical trial optimization. We cover a wide range of topics, including decentralized clinical trials (DCTs), the integration of digital health technologies (DHTs) in DCTs, and the use of Platform as a Service (PaaS) in medical device software development, to help you navigate the complex intersection of innovation and regulation. Our goal is to keep you informed and equipped with the knowledge needed to overcome industry challenges, drive innovation, and succeed in the rapidly advancing life sciences sector. Explore our blog for in-depth insights and the latest developments, and feel free to reach out if you need further assistance.
Categories:
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability Testing
ICH GCP E6 (R3): When Digital Health Became Everyone’s Responsibility
For years, Digital Health Technologies sat in an awkward middle ground in clinical trials.
Sponsors relied on them but didn’t always own them.
Vendors built them but weren’t always treated as GCP-relevant.
And regulators tolerated the ambiguity.
ICH GCP E6 (R3) quietly ends that arrangement.
ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Center
For years, Digital Health Technologies lived slightly outside the GCP spotlight.
Useful? Yes.
Innovative? Absolutely.
GCP-critical? Not always.
ICH GCP E6 (R3) changes that.

