Digital technologies are revolutionising various aspects of life, including healthcare. With advancements such as telemedicine and remote monitoring, healthcare delivery has become more connected and efficient. Digital health encompasses a range of tools including health information technology, wearable devices, and artificial intelligence. Innovations like digital therapeutics (DTx) provide evidence-based, therapeutic interventions for diseases and conditions through digital platforms. Digital health technologies, including DTx, must meet stringent regulatory standards for safety and efficacy in both Europe and the US. This includes compliance with EU Regulation 2017/745 and FDA requirements. At a very first phase of the design of a digital health technology researchers must focus on the development of the digital tool to guarantee quality, good graphic user interface, and full compliance with the GDPR. After this, the digital tool undergoes rigorous clinical validation, starting with pilot studies to assess usability and safety, followed by pivotal studies to provide robust evidence of efficacy. These studies often use randomised controlled trials to compare digital tools against placebos or standard treatments. Key issues include managing adverse effects, minimising drop-outs, and ensuring effective design. Ongoing research and collaboration among stakeholders are essential for advancing and regulating digital health technologies and digital therapeutics effectively.