The digital transformation of healthcare is a top priority for Health2047. It is a complex and fast-evolving arena that presents a number of different opportunities and challenges.

For example, we’re already seeing an explosion of growth in decentralized computing models utilizing relatively new interconnections between cloud power, edge nodes, and billions of internet of things (IoT) devices that sense and monitor surroundings and/or individual biometrics. We now have myriad and ever-multiplying avenues for healthcare function and action stretching out to the “edge” of our computational networks where novel forms of digital interaction with the physical world are taking place. 

For healthcare, this acceleration has enabled enormous capability advancement in a host of areas, including clinical data gathering, remote patient monitoring, and telehealth delivery. But at the same time, concerns about safety, security, and data protection persist. A 2020 Palo Alto Networks report found that 98% of all IoT traffic is still unencrypted; 83% of medical imaging devices are running on unsupported operating systems; and 57% of IoT devices are vulnerable to medium- or high-severity attacks. Those are troubling numbers that can’t be ignored.

There remains a tension between opportunity and challenge in transforming healthcare at the edge. At Health2047, we believe meeting both must never waver from improving healthcare safety, quality, and equity.

I recently had the opportunity to discuss this tension in a presentation for the Rethinking Digital Transformation online summit with two esteemed leaders in the space: Dr. Robert Wah, Health2047 advisor and Chair of the Board of Directors at The Commons Project Foundation, and Dr. Mira Irons, Chief Health and Science Officer of the American Medical Association (AMA). Both shared valuable insight on the ways in which edge technology is changing healthcare delivery in the US — and why safety, quality, and equity are paramount in driving the success of that evolution.

Capturing opportunity in digital healthcare today requires grasping a couple of paradigm shifts in how we think about our technology — particularly around sharing and utilizing data. One is that data doesn’t necessarily have to be transported to a central area to have value. The other is that it doesn’t necessarily need to be formatted for human consumption (rather, processing can happen at the edge of our computing networks and serve up summarized information to other layers of the network for trained clinicians and physicians to use). 

This is a pretty big and complicated leap for healthcare, and the way we manage that shift exemplifies the challenges of maintaining safety through the transformation. One specific example can be taken from the rise of self-measured blood pressure (SMBP) devices. There are now hundreds if not thousands of these devices available, and they can be of tremendous value to patients. But how do we ensure the safety of patients and soundness of practice as devices and methodologies for self-measuring and monitoring blood pressure between physician visits proliferate? Are the devices safe and clinically accurate? Have they been FDA approved? Not all of them are.

In the interest of supporting safety, the AMA helps answer some of these questions via a website called ValidateBP. It provides patients with a validated listing of clinically accurate FDA-approved devices that meet standardized technical criteria and can be used at home. And it provides manufacturers with a mechanism for achieving validation. 

There are other issues that have to be addressed as similar new technologies advance in both adoption and edge-enablement. Is the patient following a clinically approved protocol for taking their blood pressure measurements? How can the physician or trained clinician be able to look at that measurement data, understand that they’ve received it securely, that it belongs to the patient that they’re looking to help, and that that data has been shared with them maintaining patient privacy. These are the types of practical, technical, and regulatory safety challenges that any sort of digital healthcare-at-the-edge solution is going to face.

Other considerations include establishing and managing identity; dealing with different data sources and different actors in the environment; ensuring individuals can decide how they want to use their digital information for themselves or share it securely with other members of their healthcare environment; even determining how information is displayed. 

For example, as explained in our joint presentation, Dr. Wah’s work with The Commons Project aims to develop a common trust network and a registry of collaboratively compliant data sources to lay a solid foundation that enshrines data quality for next-gen applications and services. Dr. Irons’ work focuses on ensuring the physician’s perspective gets reflected in healthcare technology development, the integrity of the science, and accounting for what it takes for physicians to trust the new tools that they’re being asked to use in the care of their patients — whether it be telehealth services or the algorithms that inform the AI used in many new digital solutions. There are questions physicians want answered: Does it work? Does it work for my patients? Who is liable/accountable? Does it improve health outcomes? Does it meet expectations for ethics, evidence, and equity? Does it function with respect for patient privacy and informed consent in data use? Can it be trusted to be safe and effective? Was it developed in response to a clearly defined clinical need identified by physicians? Has it been validated through a process commensurate with its risks? Was it tested for use availability by participants who are demographically representative of the end users? And do physicians have the resources and infrastructure to implement it in an ethical and equitable manner? 

Ensuring those questions are answered and managing that tension between opportunity and challenge in healthcare’s digital transformation is important and exciting — and aligning our efforts around the themes of safety, quality, and equity is core to the advancement of healthcare, its technology, and our work at Health2047. I invite healthcare innovators who feel the same to join us. If you have an idea, if you want to work with physicians, if you’re working on a technology and you think we can be helpful to you — please do reach out. 

— Judy Barkal is Managing Director at Health2047.