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Defining regulatory compliance in digital health New and agile approaches to accelerate digital innovation in healthcare BROUGHT TO YOU BY2 Defining regulatory compliance in digital health Keeping up with digital health developments Digital health is rapidly changing the way pharma professionals predict, monitor and help to manage health. Whether it is software-as-a-medical-device (SaMD), artificial intelligence (AI), clinical practice technologies or consumer health technologies such as wearables, apps or fitness trackers, regulators must start revolutionizing their approaches to support innovation and keep pace with market growth. However, the potential of digital health goes far beyond individual technologies and software applications. At its core, digital health represents a much-needed connection between data and healthcare. While data is not new to the healthcare field, the exponential growth in both data volume and complexity throughout the healthcare value chain, as well as the adoption of new technology platforms, tools and methodologies in digital health and data analysis, bring new challenges for regulators to consider. Digitalization is changing the rules of how pharma companies traditionally do business, so finding the right digital solution to manage existing markets and develop effective pricing strategies for new drugs and devices to maximize revenue should be high on the C-suite agenda. Francesco Dellisanti, Director of Digital Health at Clarivate, says, “Clarivates definition of digital health focuses on the broad range of solutions and centers on the patient to enable health management or patient care in real-life settings. It goes beyond medical grade technologies and digital therapeutics to also embrace both consumer software and device solutions. Its really about making health more accessible beyond the traditional care set-up.” With regulatory bodies feeling the pressure to implement new models to address technology and software as a subset and to streamline a more agile way of working, we analyze the changes in digital health and what this will mean for their approval and use. In this report, we examine the challenges and opportunities of implementing digital solutions, and the impact of SaMD, big data and cybersecurity on regulatory compliance and healthcare. This report will reveal how adopting agile models and redefining regulation for digital health can: Support continuous innovation, improvement and interconnectivity Facilitate better healthcare at lower costs Improve data quality and data availability Enhance processes and product development timelines Drive personalized healthcare for patients Ensure the industry is responding to market changes faster Improve market growth and increase patients confidence in products beyond regulatory oversight3 Defining regulatory compliance in digital health Technological change is accelerating rapidly and impacting all facets of the healthcare industry, with the likes of IBM and Google making significant investments in new software. The latest technology and available software is changing the way patients manage their health, interact with their providers and change how clinicians practice medicine. Additionally, with an increasing number of peoples ill health attributed to the rapid changes in the way we live, work and play, the adoption of digital health has never been more important to promote behavioral change and adherence. In September 2019, UK Secretary of State of Health and Social Care Matt Hancock commented at Public Health Englands annual conference: “Personalized prevention enabled by the data-crunching power of AI will become the guiding principle of public health in 2020, and the increasing dominance of digital health in general, presents huge opportunities for pharma companies, and not just in terms of cost savings. “It has the potential to help pharma firms transform their relationships with the end users of their products, aiding the creation of more meaningful connections with consumers.” Hancocks remarks represent a consensus prevalent within the global health community. The World Health Organization states in its recent Global strategy on digital health 202024 draft report: “Strategic and innovative use of digital and cutting-edge information and communications technologies are an essential enabling factor toward ensuring one billion more people benefit from universal health coverage, one billion more people are better protected from health emergencies and one billion more people enjoy better health and wellbeing. ” Irrespective of the recent Covid-19 global pandemic, the report sets out a strategy that stresses the “need for a strong legal and regulatory base to protect privacy, confidentiality, integrity and availability of data, the processing of personal health data and cybersecurity, trust building, accountability and governance, ethics, equity, capacity building and literacy.” Sarah Hardison, Head of Regulatory Product at Clarivate, says: “In the digital health arena, technology is moving so quickly that drug developers, medical device developers and software developers are coming up with new concepts and new technologies faster than regulators can regulate them. “This is a key challenge the industry and regulators are working on together. Regulators have been taking steps to ensure processes are accelerated by using pre-market notifications and pre-certification programs. Therefore, you can look at a medical device or piece of software, compare it to something that already exists in the market, and avoid going through the whole regulation process again.” Digital health in practice4 Defining regulatory compliance in digital health Shifting the regulatory paradigm in software development SaMD has been defined by the US Food and Drug Administration (FDA) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” These software solutions can offer a countless number of health benefits as they enable patients to take an active role in their own healthcare. For example, mobile medical app SkinVision detects skin cancer at an early stage when it is most treatable and helps users stay on top of their skin health. According to a 2019 FDA guidance report, Policy for device software functions and mobile medical applications: “As mobile platforms become more user friendly, computationally powerful and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. Some of these new software functions are specifically targeted to assist individuals in their own health and wellness management, while other software functions are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care.” As the use of SaMD grows exponentially, there is a widespread need for innovators in digital health to understand the rapidly evolving regulatory requirements across geographies, such as when approval is required for a new solution and which regulation pathway can reduce barriers and time to market. In an effort to inspire continuous innovation and ensure software developers feel encouraged to take on such a task, the FDA is actively looking to clarify and simplify the regulatory process. In a later regulatory policy update in 2019, the FDA looked to provide clarification of its proposed analysis of Section 520(o)(1) of the FD&C Act, which defines the use of software within mobile medical applications. The policys authors noted that the software functions of SaMD were “intended to provide decision support for the diagnosis, treatment, prevention, cure or mitigation of disease or other conditions (often referred to as clinical decision support software).” The policy continued: “Section 3060 of the Cures Act created a function-specific definition and the functions excluded from the device definition under section 520(o) of the FD&C Act are independent of the platform on which they might run where appropriate, we are clarifying that the policies in the guidance documents are function-specific and apply across platforms. For example, as appropriate, instances of “mobile application” in the Mobile Medical Applications guidance has been changed to “software function,” and the title of the guidance has been revised to “Policy for Device Software Functions and Mobile Medical Applications.” Given the unique features of SaMD that extend beyond a traditional medical device or hardware product, creating a more transparent SaMD regulation processes spurs a new regulation model for the entire digital health industry. The regulations set out by national regulatory bodies such as the FDA will support pharma companies in defining their approach toward the developing field of digital healthcare5 Defining regulatory compliance in digital health Big data in digital health It is clear that data science and big data offer the opportunity to assess the effectiveness of digital health solutions and personalized medicine. Treatment responses can be tracked and compared globally, which will vastly improve workflow productivity, accelerate drug discovery, expand the number of patients who can benefit from existing medicines and reduce research costs. The ability to manage and integrate data from across the value chain after regulatory approval will certainly continue to drive trends in digital health. However, management of big data and digitalization also poses new challenges for policymakers and international legal frameworks. The use of big data in research often raises complex ethical issues around privacy and data security. Hardison says: “As we move to mobile medical applications, people are adding their health information beyond the traditional scope of hospitals and other healthcare applications, so how is this data then being used? As a society, I think we are all feeling more vulnerable about where we put our data, so its the regulators imperative to make sure that mobile medical applications are properly secure and that there are strict regulations in place about who can access the data and how that data can being used.” In an attempt to protect patients privacy on a global scale while ensuring data can be shared freely for the purpose of healthcare and research, Ursula von der Leyen, President of the European Commission, states in her 201924 political guidelines: “In order to release that potential of digital applications, balancing the flow and wide use of data while preserving high privacy, security, safety and ethical standards is essential in my first 100 days in office, I will put forward legislation for a coordinated European approach on the human and ethical implications of AI. This should also look at how we can use big data for innovations that create wealth for our societies and our businesses.” Moreover, regulatory issues can extend to the infrastructure of digital health and cyberattacks. Building an infrastructure users can trust will be key for any pharma company looking to make its mark in digital health. An article published in European Observatory on Health Systems and Policies quarterly publication Eurohealth (Volume 25, Number 2, 2019) focused on e-prescription success in Estonia. It described the success of Keyless Signature Infrastructure Blockchain technology as a way to secure eHealth records, eAmbulance and ePrescriptions, and was able to permanently protect patient records using cryptology and ensure data could not be changed by anyone other than the patient or relevant practitioner. The system gave patients total visibility and control over their own information while establishing trust. Patients were able to become active participants in the future of their own health rather than being passive suppliers of data. Clarivates Dellisanti, said, “Digital solutions typically generate vast amounts of valuable data and insights on patient behaviors and health. At Clarivate were really interested in capturing new trends in advanced analytics for clinical data at the intersection of healthcare and data science.” Thereby, maintaining public trust and confidence in data sharing is essential to improving regulation in technological developmentA call for change An increasing number of pharma and healthcare stakeholders are finding themselves becoming immersed in digital health activities. From patients and healthcare practitioners, to researchers and data scientists, stakeholders are navigating the regulatory landscape while attempting to understand how regulatory bodies are responding to a changing marketplace. Whether within the healthcare industry itself or in adjacent industries such as software and technology, life sciences stakeholders need to know how new digital health-related regulations can be universally adopted to enhance patient care. Moreover, with regulators facing mounting pressures to keep up with innovation in product development, digital healthcare can provide life science organizations with the ability to react swiftly to the needs of the market. Regulatory bodies have shown to make significant progress in addressing regulation in digital health, with the FDA updating definitions on SaMD in 2019 for more transparent use, for example. However, for the pharma industry to achieve total regulatory transformation in digital health, experts across the healthcare industry must continue contributing their thought leadership and expertise. Clarivates Hardison remarks: “Regulatory agencies want to see patients benefit from advances in science and technology. They have an obligation to make sure that it is done safely and without giving false hope. And, in some cases, it is about putting the patient at the center of drug development from the earliest stages of discovery it is about how you can use the voice of the patient to make digital health successful.” For pharma companies to succeed in new digital environments, strategic shifts in thinking must be made by going beyond traditional business models and embracing experimentation and risk taking. Developing new collaborative approaches and leveraging digital innovation within healthcare will create a cyclical ecosystem helping regulators bridge gaps in their knowledge, improve data-driven results and decision-making and build capacities beyond traditional healthcare operating models. 6 Want to learn how to efficiently stay on top of the latest digital health regulations? 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