This highlights the significant advancements in digital therapeutics (DTx) for mental health, including a variety of tools such as mobile apps, AI chatbots, and VR therapies. With an estimated 10,000 to 20,000 mobile health apps readily available, it's clear that this landscape currently lacks consistent global regulation, safety standards, and ethical oversight. The security vulnerabilities and lack of regulated and standardized approach to data governance and algorithmic bias further cause patients, regulators and clinicians to lack confidence in the integrity and use of these tools. To address these critical gaps, the IEEE SA has established a global framework of guardrails specifically for therapeutic mobile health apps, initially focusing on mental health. The global standardized frameworks are not only necessary to protect the patient’s security, privacy and safety, enable more innovation from tech developers, but also has the potential to harmonize regulatory standards worldwide and assist governments in developing their own guidelines for reviewing digital mental health devices and therapeutics.

As the practice leader, Maria is focused on engaging and leading a global community of multi-disciplinary volunteer experts to openly collaborate and develop solutions to enable trust in and validation of breakthrough technologies/applications that will enable sustainable equitable access to quality care and improve wellness for all. Maria is an entrepreneur having founded various companies including DisruptiveRx™ Media, the first information company to explain viable use cases as blockchain/DLTs in the bio/pharma value chain. Maria’s professional highlights include global brand and communications director for one of the world’s largest mining investment platforms in Africa; and bringing innovative communication and information products to global markets and various industries including financial, bio/pharmaceutical, agriculture, natural resources, and telecommunications. Maria currently holds an MBA from the Rutgers Graduate School of Business and a BA and BS from Rutgers College at Rutgers University, the State University of New Jersey. She is an accomplished leader, public speaker, and writer having presented at various industry events and published blogs and articles in trade and peer-review publications.