Findings
There is a need for rapid development of solutions for monitoring Long COVID symptoms due to their variability and lack of treatment options.
Barriers include patient acceptability and the healthcare system’s readiness for new technologies like vocal biomarkers.
The health status of patients, particularly those with severe symptoms, may limit their ability to participate in regular voice recordings, affecting adherence.
Recommendations
Involve end users in the co-design of digital health solutions to ensure they meet needs and expectations.
Develop telemonitoring solutions that allow for accurate follow-up and complement on-site evaluations.
Implement feedback loops to improve both the solution and the algorithm through lessons learned in population studies.
Ensure that voice data collection is diverse enough to represent the target population and decrease systemic biases.
Obtain explicit consent prior to voice data collection to comply with data protection regulations.
Regulatory Considerations
Voice data is considered identifying and sensitive, requiring compliance with various data protection laws.
Explicit consent is necessary for voice data collection to minimize future risks.
Validation through clinical trials is required to prove clinical benefit, effectiveness, and security.
CE marking or FDA certification will be mandatory to bring the solution to market.
Requests for reimbursement can be made after proving the clinical and economic interest of the digital system.