Digital Health Tools are Expanding in Scope and Function to Aid Patient Diagnosis, Treatment and Monitoring, Says New Report from The IQVIA Institute

• The number of digital health apps stands at 337,000, with disease-specific apps that bring more value to health systems growing in number and their focus expanding beyond mental health and chronic diseases to encompass other conditions.
• Approval and reimbursement of digital tools is accelerating as payers recognize clinical utility and cost savings; of the more than 360 software-based digital therapies commercially available, 140 prescription digital therapeutics (DTx) are approved for patient use at home and over 220 therapies are used within digital care or in clinics.
• Sensor-based digital biomarkers that track patient health using wearables now monitor patients in care and research, and the first digital endpoints have been approved by regulators in the U.S. and Europe.
• More than 103 digital diagnostics for disease assessment are now commercially available and used to evaluate disease risk, accelerate diagnosis and monitor patient health; many of these are enabled by artificial intelligence and machine learning (AI/ML).

Despite a drop in venture funding for digital health companies over the last two-and-a-half years, digital health products and solutions are expanding in scope and function to aid patient diagnosis, treatment, and monitoring. More solutions are now focused on specific diseases, and their commercial appeal has grown as developers build solutions that bring value back to providers, are more easily integrated with health systems, and embrace innovation such as AI to personalize care and reduce provider workload. Product types have also expanded, with health assessment tools such as digital diagnostics, sensor-based digital measures, and remote patient monitoring solutions joining digital therapeutics and consumer health apps to offer value for personal health and clinical care. These findings are based on a new report from the IQVIA Institute for Human Data Science: Digital Health Trends 2024: Implications for Research and Patient Care.

There are currently 337,000 digital health apps along with more than 360 software-based digital therapies and 103 digital diagnostics commercially available. Simultaneously, the number of AI/ML enabled mobile and point-of-care devices is growing.

"The landscape of digital health has evolved over the past two years, yielding new products that are more commercially viable and meet the needs of stakeholders across a broadening set of uses," said Murray Aitken, executive director, IQVIA Institute for Human Data Science. "Digital health tools now support both patients and providers as they move from diagnosis to treatment and disease monitoring, with their scope expanding as new health assessment tools such as digital diagnostics have joined more mature digital therapies, accelerating care and closing gaps to improve health outcomes. Ultimately, these solutions will better fit into existing care pathways and bring benefits to more segments of patients and health systems."

A few key highlights of the report include:

• Digital health apps: Among the 337,000 digital health apps currently available, disease-specific apps continue to grow in number. While many continue to support mental health and patients with diabetes and cardiovascular diseases, recently-launched apps also help those with visual impairments, auditory issues and dermatologic conditions. Since app stores first emerged in 2008, over 1 million digital health apps have been created. However, two-thirds of these are no longer marketed, reflecting a high level of churn as many developers failed to differentiate their apps, consumer/patient uptake is relatively slow and financial returns have been meager. Apps with stronger clinical evidence have seen higher rates of use and more rapid uptake, indicating it is a key driver of consumer adoption and commercial success, as increased stakeholder focus is placed on evidence generation.
• Digital therapeutics: Approvals and adoption of DTx, which treat or alleviate disease by delivering a medical intervention, have proliferated as opportunities to gain regulatory approval and reimbursement grow; 140 have received approval in one or more countries and are intended for patient use at home and more than 220 software-based digital therapies are being used by providers within digital care programs or in their clinics, totaling more than 360 commercially-available digital therapies. The most progress has been seen in Germany, which has led the regulatory process and reimburses for 56 DTx, followed by the U.S. with 46 approved and the UK with 20. Along with behavioral approaches to treat mental health and chronic diseases such as diabetes and hypertension, recently approved DTx use biofeedback and virtual reality to reduce various types of pain, treat visual impairments, support respiratory and post-stroke neurological rehabilitation, and treat PTSD and phobias.
• Sensor-based digital measures: Through the use of digital sensors and wearables, nuanced aspects of health and patient experience are becoming traceable and measurable in daily life. In patient care and in clinical development programs for innovative medicines, sensor-based measures, including digital biomarkers and clinical outcome assessments, are proving valuable to remotely monitor patients, demonstrate the effects of therapeutic interventions and track outcomes. Life sciences companies have invested in the creation and validation of new digital endpoints, with some even building molecule-to-market digital strategies that overlay their drug development programs. By offering higher quality of data capture, more consistent measurements and increased sensitivity than traditional methods, some digital endpoints have optimized clinical development, allowing trial sponsors to reduce clinical trial enrollment and further promise to reduce trial duration and the need for patients to travel to trial sites. The first sensor-based digital endpoints using wearables have also been formally approved for ongoing use in clinical trials by regulators in the U.S. and Europe.
• Digital diagnostics: Software-based devices that process signals from sensors have rapidly opened new routes to assess disease risk, accelerate diagnosis, monitor patient health and assess patient prognosis; and at least 103 such digital diagnostics are now commercially available. Notably, these digital health assessment tools are bringing new options to screen undiagnosed patients for diseases and enable providers to monitor patients remotely. Conditions now detectable using these tools include autism and autism spectrum disorders, sleep apnea, atrial fibrillation, skin cancers, epilepsy and sepsis, among others.
• Use of AI/ML: Many health assessment devices are enabled by AI/ML, and in the U.S., around 75 of these mobile and point-of-care tools have been approved by the FDA. This fits within a broader trend toward using AI to improve diagnostic equipment, and as of June 2024, 801 distinct AI/ML-enabled devices have received approval from the FDA.
• Remote patient monitoring: Digital tools such as wearables and symptom-tracking apps are being combined into broader clinical platform solutions for providers to monitor disease progression or response to therapy, detect recurrence and even predict future health changes to triage patients in greatest need of care. This has enabled the creation of hospital-at-home solutions that continuously detect and predict adverse events, thereby speeding patient discharge from hospital settings and improving quality of life for patients being treated with advanced therapies and medicines with higher risk profiles. Growth in this area has also spurred the creation of accelerated approval and reimbursement pathways for remote monitoring technologies.
• The uptake of digital health technologies: While the overall uptake of digital health technologies is rising, over the past two years it has been relatively limited and less than required to sustain high levels of investment, leading to multiple exits and restructuring by developers. Stakeholders in the digital health ecosystem are working through the regulatory and reimbursement challenges to attain sustainable investment and scaling of use that will provide maximum benefits to patients and health systems. The long-term potential for technology-supported and AI/ML-driven digital health interventions remains high despite near-term challenges.

About the IQVIA Institute for Human Data Science

The IQVIA Institute for Human Data Science contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data.

Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved human outcomes. With access to IQVIA's institutional knowledge, advanced analytics, technology and unparalleled data, the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science, including government agencies, academic institutions, the life sciences industry, and payers. More information about the IQVIA Institute can be found at www.IQVIAInstitute.org.

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA's portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA's insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behavior and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

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