From smart pacemakers to diagnostic algorithms and digital therapeutics, medicine is becoming more digitized every year. Digital medicine tools offer the possibility of improved health outcomes, lower costs, and better access to care. But the evidence base for the safety and effectiveness of these new products has not kept pace with their development. Given the great divide between the promised benefits of digital medicine and its potential risks, we need to know — not just believe — that the tools we use are trustworthy.
Organizations like the Food and Drug Administration are increasingly trying to convene clinicians, engineers, and others to work together on digital medicine technologies. In January, for example, the FDA announced a new initiative called #WeHeartHackers that encourages medical device manufacturers and security experts to work more collaboratively to bring better and safer products to market.
But we need another key element for such communities to work together successfully: a professional society that brings technologists and data scientists into the fold to work alongside clinicians, researchers, and others within the traditional health care system.
With that goal in mind, we are collaborating with connected technology experts — software engineers, designers, security researchers, citizen scientists, medical professionals, and more — to launch the Digital Medicine Society (DiMe), a professional organization for those from all disciplines that comprise the diverse field of digital medicine. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, DiMe invites participation from all sectors to ensure that digital medicine realizes its full potential to improve human health.
Let’s say you’re a physician and you want to track your patient’s blood pressure remotely. How do you know which connected technologies are trustworthy and will allow your patient to direct how her data would be used and shared? Currently, it’s nearly impossible to know which, if any, digital health technologies have evidence to support their impact on patient and citizen outcomes and which ones might do harm.
Doctors are not trained to read end-user license agreements. Most engineers don’t work with patients every day to know how they’d use a digital health product. Experts from across different domains aren’t yet familiar enough with each other’s fields to embrace new paradigms. Regulators, payers, and safety-focused organizations require expert input from other disciplines to swiftly modernize their approaches to ensure that we are all able to safely reap the benefits that digital medicine may offer.
To thrive, digital medicine requires an unprecedented level of interdisciplinary collaboration. Yet the field’s potential experts exist within many silos that have yet to sprout connections with colleagues across the health care-technology divide.
To address these challenges, DiMe is developing custom research to build more evidence in the field, training practitioners to safely and ethically adopt these tools, and building out online and in-person communities for digital medicine practitioners to work together.
DiMe joins two existing entities, the Digital Therapeutics Alliance, a trade association, and NODE.health, an evidence-based digital medicine organization, that have been forging ahead to support the companies and institutions that are bringing digital products to market. DiMe is aligning with these entities to provide a professional home for individuals working in digital medicine.
It is essential that this new generation of medical professionals abide by the same “do not harm” ethos as traditional physicians. To support that goal, in 2016 researchers introduced the Hippocratic Oath for Connected Medical Devices, which outlines five principles for modernizing the oath with clear language, technically sound objectives, and more of a cybersecurity focus. The team behind the Hippocratic Oath for Connected Medical Devices, I Am The Cavalry, is a grassroots group of white-hat hackers who work collaboratively with industry and governments to address cybersecurity issues in areas such as health care, aviation, and transportation. The FDA has since taken notice. Its cybersecurity team now regularly attends DEF CON’s Biohacking Village, and has also issued pre- and post-market security guidance that incorporates many principles found in the Hippocratic Oath for Connected Medical Devices.
No individual or group holds the key to a better health care system. That’s why we need to bring together expert clinicians, ethicists, regulators, engineers, cybersecurity professionals, and more. These groups bring their own sets of ontologies and ways of considering the world, and collaborations between them will create the best path for patients. From initiatives as simple as ensuring that everyone at the table is using the same definition of “validation” to defining adequate evidentiary frameworks for all end users of digital technologies, DiMe aims to engage, focus, and convene experts to contribute to activities that advance digital medicine for the greatest good.
Our dependence on connected technologies has been increasing faster than our ability to safeguard ourselves. It’s time to bring together a principled group of digital medicine practitioners to ensure that the technologies we bring to market are worthy of the trust we place in them. We invite you to join us.
Jen Goldsack is the interim executive director of the Digital Medicine Society and vice president of digital measurement at monARC Bionetworks. Beau Woods is a leader with the I Am The Cavalry initiative, a Cyber Safety Innovation Fellow at the Atlantic Council, founder/CEO of Stratigos Security, and runs the Biohacking Village: Device Lab at DEF CON. Eric Perakslis is a Rubenstein Fellow at Duke University, a lecturer in the Department of Biomedical Informatics at Harvard Medical School, and strategic innovation advisor at Médecins Sans Frontières.