Proving the Business Case for the Internet of Things

WellDoc publishes framework for creating mhealth hardware and software

Steve Rogerson
March 2, 2016
Baltimore-based digital health technology company WellDoc has published a framework for creating digital therapeutics technologies to treat chronic diseases. The framework provides guidelines for producers of digital therapeutics applications (apps), mobile devices and other portable mhealth software and hardware.
Published in the JMIR Research Protocols, it integrates health behaviour research, clinical trials and software technology, with the aim of creating more effective technology that leverages real-time coaching and feedback to improve self-management of chronic disease.
Currently, mobile technology has shown promise to revolutionise health services and patient self management, but has not been proven to be very effective at changing health behaviours and outcomes. Many apps and mobile digital health technologies do not have structures that were designed in alignment with clinical trials results in chronic diseases, or with knowledge of health behaviours and effective intervention strategies for patients with chronic disease.
“This framework for the development of mobile health apps and digital therapeutics fills an important need for scalability, replicability and evidence-based information in medical mobile technology design,” said Anand Iyer, WellDoc’s chief strategy officer. “We see this as a best practices playbook for the health IT ecosystem at large. Adopting the steps and processes outlined in our manuscript can help create effective technologies for different levels of many chronic diseases, and for apps that provide general healthcare information to US Food & Drug Administration (FDA)-cleared technologies that provide customised, dynamic and adaptive interventions to manage chronic conditions.”
The framework was incorporated into the design and manufacture of BlueStar, WellDoc’s digital therapeutic to address behaviours and outcomes in type two diabetes, and constitutes a systematic approach to mobile health technology development.
It consists of a seven step waterfall process, in which outcomes and metrics, programme objectives, changes in essential behaviours, customisation and individual experience, evidence-based clinical and behavioural knowledge as well as value drivers such as improved health, access or reduced costs, all determine the features and content of an app or other digital therapeutics technology.
Features in the final product can include educational videos, tips, a patient logbook, real-time feedback, medication adherence tools, tailored reports to providers and time-based touchpoint messages, or other tools that the waterfall research and development process identified as valuable for changing health outcomes.
The framework was designed for initial use in managing type two diabetes, but it has been customised and applied to prototypes in other diseases, such as epilepsy, asthma, chronic obstructive pulmonary disease, HER2+ breast cancer and low back pain. The design process intentionally focuses on technology intervention for the patient without a reliance on human intervention.
WellDoc is a digital health technology company that develops mobile products to drive behavioural and clinical change in chronic disease.