Developing software for the healthcare industry requires a robust understanding and adherence to several key development standards to ensure safety, efficacy, and security.
Digitals for Health can help you to navigate this, often complex, aspect of the software development process. Healthcare software and IT systems are regulated under international standards like ISO 81001-1:2021, which provides principles, concepts, and definitions for key properties like safety, effectiveness, and security across the full life cycle, from concept to decommissioning.
Telehealth Product Regulatory Guidelines Aligned with Healthcare Development Standards
Depending on the nature of the software, developers need to follow different guidelines, such as those developed for telehealth products. These guidelines are meant to help manufacturers, developers, and importers determine if their device, software, or app falls under regulated medical devices, and to understand the relevant regulatory requirements.
Digital Health Product Innovation Support
Certain jurisdictions offer pathways for immediate registration of standalone software and mobile applications. These pathways leverage the regulatory review and approval from reference regulatory agencies and allow immediate market access upon successful submission of a product registration application.
Device Development Consultation Scheme
This scheme provides consultation to researchers, developers, and manufacturers of digital health devices, software, apps, and AI solutions. These consultations often form a large portion of the product development process and can help to ensure that products meet the required regulatory standards.
Regulatory Guidelines for Software Medical Devices
To mitigate digital threats such as cybersecurity, data integrity, and data security, specific guidelines were formulated for managing software in medical devices across their complete lifecycle in accordance with healthcare development standards.
Artificial Intelligence (AI) in Healthcare Development Standards
These guidelines encourage the safe development and implementation of AI-Medical Devices and provide clarity to industry stakeholders on regulatory requirements.
The IMDRF is working to harmonise the definition of a medical device, its classification, and requirements across different jurisdictions.