While pharmacogenomics has traditionally been the domain of academic research, policymakers are now showing a burgeoning interest in its potential to enhance patient outcomes and mounting evidence from the pharmaceutical industry is fueling interest in this field.
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), discusses the society’s new project aimed at researching global regulations for digital health to create a foundation for approval and patient access that can cut across regions.
“The solution provider that builds the device and creates the algorithm should consider integration and accountability among multiple other challenges. But meeting the needs of the third element in the equation, the doctors, is key.”
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
The second part of this two-article series on digital therapeutics (DTx) sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success.
Digital therapeutics (DTx) have the potential to lower healthcare costs and improve patient compliance, outcomes and access to care. In the first part of this two-article series we look at the current and potential applications for this growing sector of digital health as well as key considerations for technology developers.
