Whether it’s software as a medical device, clinical decision support (CDS), artificial intelligence and health IT systems – or more consumer-facing technology like mHealth apps, fitness trackers, wearable devices and telehealth systems – digital health is rapidly changing how we predict, monitor, manage and make decisions about health. To help – not hinder – the digital health revolution, the time has come for legislators and regulating bodies across the globe to reimagine their approaches to digital health regulation.
Pioneering technologies can detect the risk of disease, predict how a disease may progress and enable the right treatment decision at the outset. Software solutions that support these tests and devices are becoming an integral part of decision making along the entire continuum of a patient’s health or disease, enabling physicians to make full use ofin vitro diagnostics (IVDs) along the healthcare value chain. Digital health software empowers patients to gain control over chronic conditions by enabling both physicians and patients to monitor treatment progress. And, through its ability to rapidly connect dots between patients, healthcare professionals, evidence-based research and even between biomarkers and disease indicators, digital health provides data-driven results to support life-changing decisions.
Medical software that informs on diagnosis and effective treatment decisions – and software that streamlines workflows – can lead to more efficient clinical practice, ultimately enabling better healthcare at lower costs. In addition, digital health equips patients and consumers with real-time information to support better decisions about their own health, which also has potential to improve outcomes while lowering the cost of care. Both directly and indirectly, digital health technology provides many benefits to patients:
360° patient profile for clinical decision support: Digital health allows vast amounts of data to be consolidated onto one platform to create a 360-degree patient profile for physicians and other healthcare professionals to use in making faster, more informed decisions.
Patient engagement: Organising patient data into user-friendly profiles assists patients and caregivers in making their own healthcare decisions.
Consumer engagement: Digital health empowers consumers to make smarter everyday decisions about matters related to health, wellness and fitness.
Improved treatments: Digital health also empowers physicians and other healthcare professionals to quickly access libraries of information regarding disease states, treatments and innovations that may help determine faster, more effective treatments for patients.
Artificial intelligence: Digital health fuels itself. With artificial intelligence and algorithms, enormous amounts of Real World Evidence can be leveraged to deliver self-learning products that constantly update available data and help healthcare professionals make more timely and informed healthcare treatment decisions.
In many cases, these benefits are made possible through technology referred to as Software as a Medical Device (or SaMD),1 such as IVDs and CDS systems that perform medical functions but do not affect the function of any associated hardware. In cases where risk is low but benefits are rich, how can health authorities adapt policy in ways that expedite access to the far-reaching benefits of digital health software? The answer lies in risk-based regulatory requirements that fit the nature and purpose of software thereby lifting unnecessary regulatory barriers that delay the path to market for new and improved digital health solutions.
Current regulations do not fit the rapid, iterative nature of software. They treat digital health software the same as hardware-based medical devices. However, for the following reasons, this one-size-fits-all approach is ill-suited to medical software regulation:
Digital health software lifecycles are short, characterised by constant change and delivery. The current regulatory paradigm was established for hardware-based devices, assays and similar products. These have long development and iteration timelines, and the FDA pre-market review framework was established with such timelines in mind. By contrast, the timelines for digital health devices are much shorter, especially for iterations. Therefore, when health authorities apply the same pre-market development processes, quality management system and associated timelines for software as they do for traditional IVDs and medical devices, it raises barriers to innovative new software and modifications, and strains the existing systems. The end result is delayed access.
Digital health manufacturers must also respond quickly to bugs, adverse events and other concerns, but current regulations apply the existing framework to modifications as well as to new products. As a result, current regulatory frameworks impede the developer’s ability to rapidly and continuously improve safety and effectiveness of their software products.
To support rapid innovation and more robust digital health integration, the health industry needs modernised regulatory frameworks that consider the uniquely iterative nature of software. Creating a swifter, more predictable regulatory pathway can help reduce the time and cost of market entry, ensuring an appropriately streamlined path to increasingly advanced – and increasingly connected – digital health technology.
The tides are changing in many areas of the world. Through the International Medical Device Regulators Forum (IMDRF), regulators from the U.S., Europe, Australia, Brazil, China, Japan, Russia, Singapore, South Korea and Canada jointly acknowledge the challenge of digital health regulation, and they recommend policies commensurate with the risk posed by the specific SaMD.2
We are seeing the effects of that recommendation take shape in the U.S. To fan the winds of change with regard to SaMD regulation, U.S. legislators enacted the 21st Century Cures Act,3 which excludes certain low-risk software functions and intended uses from the definition of a medical device. The U.S. Food and Drug Administration (FDA) has taken a proactive approach towards driving digital health innovation by implementing the Digital Health Innovation Action Plan.4 As an outcome of that, the FDA has published draft guidance, such as Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,5 and Clinical and Patient Decision Support Software.6 Further, the FDA has launched the Software Pre-Certification Pilot Program to test the safety and efficacy of pre-certifying software developers as a streamlined pathway for regulatory review. Roche is honoured to be one of nine digital health innovators participating in the Pre-Cert Pilot Program, which is designed to inform a tailored approach to regulation by evaluating five excellence principles at the organisational level: patient safety, product quality, clinical responsibility, cybersecurity responsibility and proactive culture.
That organisational excellence appraisal is the first of four proposed key components of the FDA Pre-Cert Pilot Program.7 Once an organisation demonstrates excellence, it can become pre-certified, and pre-certified status may offer a streamlined path for pre-market product review. The second component is review determination, which takes into account the risk categories set up by IMDRF guidelines with regard to the software’s intended purpose (informs decisions, drives clinical management, or aids in diagnosis or treatment) as well as the severity of the disease state for which the software will be used (critical, serious or non-serious). These considerations help determine if a given SaMD product is subject to FDA review.
For SaMD products that are subject to FDA review, the third component is streamlined review, which is designed to ensure regulators look at the right things while not duplicating what has already been assessed. The fourth and final component is real world performance. Because the software development cycle is rapid and highly iterative, regulators can look at the real world performance of the software after it reaches the market, knowing that an organisation with pre-certified excellence will change that software over time, and it will have appropriate processes in place to do so safely and effectively. Within this model, the FDA still receives and assesses the information it needs, but it does so throughout the entire process.
At Roche Diagnostics, we commend the FDA for taking a collaborative, transparent and agile approach to developing a “fit for purpose” regulatory framework for SaMD. It is a major step forward in addressing the need to bring new digital health technologies to market faster, while still protecting patients through appropriate, risk-based levels of government oversight. We also believe the benefits of the Pre-Cert Program extend beyond digital health innovation and into public health outcomes because it:
Encourages companies to strive for excellence, beyond basic compliance
Promotes high-quality and effective innovation
Increases user confidence beyond regulatory oversight through transparent FDA pre-certified status
Allows the FDA to focus resources on higher-risk digital health developers and products
Bottom line: The safety standards should not change, but software-tailored, risk-based regulatory models can accelerate the path to consumers for better everyday health decisions. As software-based medical technologies become “smarter” and more connected over time, they offer tremendous opportunity to make an ever-increasing impact. The more questions we answer, the more lives we save – and digital health is a powerful catalyst for better health, one that can deliver more information to more people…faster. We are committed to driving innovation in digital health and partnering with FDA and global health authorities to drive for a fit for purpose regulatory paradigm – doing now what patients need next.
IMDRF SaMD Working Group. “Software as a Medical Device (SaMD): Key Definitions” (2013). Available at:
IMDRF Software as a Medical Device (SaMD) Working Group. “’Software as a Medical Device’: Possible Framework for Risk Categorization and Corresponding Considerations” (2014). Available at:
U.S. Food and Drug Administration. “21st Century Cures Act” [Online]. Available at: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm (Accessed: October 2018)
U.S. Food and Drug Administration, Center for Devices and Radiological Health Digital Health Program. “Digital Health Innovation Action Plan” (2017). Available at:
U.S. Food and Drug Administration. “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Draft Guidance for Industry and Food and Drug Administration Staff” (2017). Available at:
U.S. Food and Drug Administration. “Clinical and Patient Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff” (2017). Available at:
U.S. Food and Drug Administration. “Digital Health Software Precertification (Pre-Cert) Program” [Online]. Available at:
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