By Dr. Harietta Eleftherochorinou, vice president 0f innovation ventures, IQVIA.
Patients, health systems and CROs are embracing digital health, as indicated by the number of digital health apps, digital diagnostics, digital biomarkers, digital therapeutics and devices being created. At the same time, over a third of these apps don’t survive longer than a year, devices struggle to get regulatory approval, digital biomarkers are yet to be proven, while digital diagnostics and digital therapeutics are not cheaper alternatives to the standard of care. The question skeptics therefore have is “what is the real value of digital health to patients and the healthcare systems?” Below, there are several tangible value-points of digital health in quantified metrics to give an answer.
The digital health innovation market is experiencing exponential growth. Investments of $24 billion were made globally in digital health in 2020 according to the IQVIA Institute Digital Health Trends 2021 report. And according to CBInsights, in 2021, $39.6 billion were invested on digital health alone, out of the total $100 billion invested globally in healthcare startups. These investments are resulting in greater numbers of mobile apps, wearable devices and other digital tools.
Digital apps are redefining the health experience
Multiple types of digital health tools contributed to mitigating the impact of the pandemic and are now established part of the digital health landscape. Consumer apps remain the most widely available and used digital tool with more than 90,000 new digital health apps added in 2020 — an average of more than 250 apps per day — resulting in over 350,000 apps currently available. Apps are increasingly focused on health condition management rather than wellness management, with the former now accounting for 47% of all apps in 2020, up from 28% in 2015, and with mental health, diabetes and cardiovascular disease-related apps accounting for almost half of disease-specific apps. Downloads and use of apps are heavily skewed with 83% of apps being installed fewer than 5,000 times and collectively accounting for less than 1% of total downloads, while a cohort of 110 apps have each been downloaded more than 10 million times and in aggregate make up almost 50% of total downloads.
Moreover, patients have easy, mobile access to health information and quality healthcare. For example, the Moodpath app allows users to track their mental health through cognitive behavioral therapy. At the same time, mobile apps connect doctors with patients who need assistance in real-time, thus easing the burden on healthcare workers. HealthTap is one such mobile app which offers 24×7 virtual assistance to patients by connecting them to certified doctors through call, text, or video call. .The value is increased patient engagement, patient education on one’s own condition and patient centricity coming to life rather than talked about.
Positive results from digital therapeutics
With the incorporation of technology to assist with the treating, preventing and managing of specific diseases, innovation amongst digital therapeutics and digital care products is increasing. According to the IQVIA report, Digital Therapeutics (DTx), and Digital Care (DC) products — incorporating software to treat, prevent or manage specific diseases or conditions — have been proliferating. Over 250 such products are now identified, including about 150 products that are commercially available, and the rest in development.
Digital therapeutics, which typically focus on a narrow clinical indication and generate evidence of clinical efficacy, follow a development path that typically requires market authorization by a regulatory body and sometimes a prescription from a provider, though some may be exempt. Neurologic and psychiatric conditions are a key focus of both DTx and DCs, making up over two-thirds of all DTx indications and over 40% of DCs, respectively, with DCs also used by patients suffering from endocrinology, oncology and cardiovascular conditions.
Patient centricity has quickly become the biggest buzzword in medicine and clinical research – but it is much more than a trend. Patient centric clinical research allows the healthcare industry to deliver more holistic outcomes for patients, meaning that new treatments not only deliver the desired outcome, but also leave intact or even improve the patient’s quality of life while they are undergoing treatment. As a result of this shift, implementing strategies for capturing the patient’s voice in clinical research has become a top priority for the biopharma industry.
Patients today certainly have more advocacy and are playing a more active role in clinical trial planning and data collection as a condition of their participation, which is a major contributor to this shift. However, regulators and payers are also driving the shift by showing increasing interest in the perspectives of patients as they review submissions for new drug approvals. Electronic clinical outcomes assessments (eCOAs) have emerged as an effective approach to capturing these patient insights that can make or break the trial by giving them a structured platform for reporting their experiences and capturing those reports in measurable and meaningful ways.
What are eCOAs?
An eCOA is a digital approach to capturing patient experience data in traditional clinical trials and real-world studies. During the pandemic, eCOAs shot to prominence in the research space as sponsors sought out more agile tools to capture patient data remotely. At this critical point in time for agile research, eCOAs made it easier for investigators and sponsors to keep track of patient progress outside of the site environment’s confines and collect more patient-specific information to support the safety and efficacy of treatments and their impact on patients’ quality of life.
eCOAs are custom-built interactive assessments that clinical trial participants are prompted to respond to, through provided or personal devices. They allow patients, clinicians, and caregivers to directly report outcomes, supplying real-time insights, and high-quality data collection. These digital assessments have led the way in simplifying patient engagement and amplifying the voice and experience of patience.
By Angela Kennedy, director of strategic operations, medical specialty societies, IQVIA.
In 2016, the 21st Century Cures Act (Cures Act) resulted in new regulations that fundamentally changed the way deidentified patient data is accessed and utilized. However, data quality and interoperability between the various healthcare stakeholders has been a major hurdle.
When it comes to implementing the Cures Act, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) each must administer the law’s requirements. Therefore, each agency has released a final rule over their respective jurisdiction.
Information blocking is a primary focus of the ONC final rule, which also requires that developers certified by the ONC Health IT Certification Program must have standardized Application Programming Interfaces (APIs) and implement Fast Healthcare Interoperability Resources (FHIR) technology, enabling individuals to access structured electronic health information securely and easily.
These advancements will only make information sharing easier. The CMS Interoperability and Patient Access final rule also focuses on API interoperability, requiring federal payers to make provider directory information publicly available. Specifically, it encourages interoperability and patient access to health information.
In a major step to ensure open sharing of information, the ONC introduced the US Core Data for Interoperability (USCDI). Since ONC is the certifying body for EHRs, providers must be prepared to transition to a new “Cures Edition” version of its software before the end of 2022.
What is USCDI?
USCDI encompasses a standard for data creation, a set of defined data classes and elements that Electronic Health Record (EHR) vendors must be able to provide. This creates an expectation for open and free access to healthcare data by industry stakeholders, including physicians, insurers, labs, registries, and the patients themselves. CMS requires that payers share the USCDI data they maintain with patients via the Patient Access API and with other payers via the Payer-to-Payer Data Exchange.
While some organizations have used APIs to aid the exchange of data, experts in the healthcare industry have been aware that for a truly free and open data exchange to work, modern technology and standards need to be put in place. This is where FHIR comes in.
What is FHIR?
FHIR is based on a new iteration of Representational State Transfer (REST) designs, which uses HTTP to enable the exchange of information between applications. That means if two applications adhere to the standards outlined for REST technologies, it makes it easier for two applications to exchange and manage healthcare data regardless of how it is stored. Not only do these applications now speak the same language, but FHIR has also created categories for certain healthcare interactions to further refine the data exchange by making it easily identifiable within each system.