Conducting rare disease clinical trials can be challenging because of small and geographically dispersed groups of patients who may face difficulties in travelling to trial sites. Regulatory requirements for cell and gene therapies, even if only administered once, require long-term follow ups that extend for many years and provide an ongoing burden for patients. Jeeva Informatics Solutions is seeking to address those challenges through it harnessing of digital health technologies to bring the trial to the patient. We spoke to Harsha Rajasimha, founder and CEO of Jeeva, about the challenges of conducting rare disease clinical trials, the potential of digital health technologies to address those issues, and how ready regulators and sponsors may be to embrace these technologies to transform the way they conduct clinical trials today.