What are the current challenges impacting the use of digital biomarkers?
Digital biomarkers have a high degree of ambiguity in semantics, primarily because of the merging of several fields (healthcare, engineering and analytics). There is consequently a lack of standardisation in the terminology for novel concepts such as longitudinal data, as well as multiple definitions for the term “digital biomarker” itself in scientific literature. The FDA has addressed some matters regarding these semantics, highlighting that conflating terms can “hamper communication and evidence expectations between medical product developers and regulators.”
The complexity of regulatory control is currently one of the factors hindering innovation around digital biomarkers. Due to deficits in standardisation, as well as their vast applications across drugs, biological and medical devices, there is no consistent regulatory framework that applies to them. The industry is currently faced with minimal guidelines on how to maintain and store the data gathered, which could lead to gross misuse of confidential patient information. There have also been increasing problems around how to correctly analyse and use accurate baselines to identify and interpret pertinent data, due to a lack of research on the topic.
The Health Level Seven (HL7) International organisation suggested the Fast Healthcare Interoperability Resources (FHIR) standard to help make digital data more systematic and interpretable. The procedure of converting data into digital biomarkers has however inflated costs, partially due to the lack of standards and validation protocols in research around their use.
Popular devices like Apple watches and smartphones have also suffered from a cloud of suspicion and disbelief surrounding their clinical validity. Though the ECG app and irregular rhythm notifications for Apple are now CE marked, most health functions are not CE marked or FDA approved. According to the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry, as well as a collaboration between international regulatory bodies, both the CE mark and FDA approval are important for the successful adoption of digital endpoints.