Every digital therapeutic manufacturer must design DTx products using a human-centered approach and account for the user’s core needs, their environment, and the types of devices that will be used. While some digital therapeutics are purely software-based, others are paired with hardware components, such as wearable and wireless devices, biometric sensors, and diagnostic products.
No matter how many components are integrated into a DTx product, it is crucial for product developers to engage end users – including patients, caregivers, and healthcare providers – every step of the way.
This patient-centered focus enables digital therapeutics to more seamlessly blend into clinical guidelines, care delivery systems, and patient lives in the privacy of their own environment.
Additional ways that product developers must protect patients is through the integration of product quality, security, and maintenance best practices, including:
- Passing and obtaining appropriate security and vulnerability certifications, including standards-based guidelines to safeguard data at rest and in-transit through proper authentication, encryption, and other methods.
- Ensuring compliance with all applicable electronic Protected Health Information (ePHI) regulations.
- Monitoring changing external security environments, with a focus on how to protect patient and customer private information.
- Employing a system that identifies, monitors, and addresses adverse events to detect and correct problems in a timely manner.
- Complying with international and national certifications and standards.
- Establishing and adhering to quality systems to ensure that products consistently meet applicable requirements and specifications.