EQUALCARE
Registry

EQUAL CARE® Certification

FemTech

Evaluation Criteria
Evaluation Items
Evaluation Description
Methodology
Healthcare Gap Relevance
Evaluation Description
The extent to which an intervention effectively addresses and mitigates disparities in healthcare access, quality, and outcomes. Ensure the intervention contributes to closing the healthcare gaps that exist due to gender-related factors.
Methodology
Assess the extent to which an intervention effectively addresses and mitigates disparities in healthcare access, quality, and outcomes. Companies must demonstrate how their intervention contributes to closing healthcare gaps that exist due to gender-related factors. This includes providing evidence that the intervention improves equitable access to healthcare services, enhances the quality of care, and leads to better health outcomes for all genders. Companies should document the specific strategies and measures they have implemented to address these disparities and provide data showing the impact of their intervention on reducing gender-based healthcare inequalities.
Efficacy/ Accuracy
Evaluation Description
Gender-segregated data for efficacy.
Methodology
Companies must provide evidence showing the effectiveness of their application for different genders, demonstrating that it performs well across these groups.
Accessibility
Evaluation Description
Accessibility of UI Design, Content, Documentation and Help. Compliance with Accessibility Standards
Methodology
Ensure all users, including those with disabilities, can effectively perceive, understand, navigate, and interact with the application. Compliance with requirements and guidelines on useability for example ISO/IEC 62366, ISO 9241 or FDA.
Affordability
Evaluation Description
Costs associated with the application for Users, Healthcare Professionals and Organizations.
Methodology
Describe the cost model associated with the application for users, healthcare professionals, and organizations. Companies must provide information, contact or reference.
Possible Side Effects
Evaluation Description
Evidence of any possible side effects or absences of them.
Methodology
Provide evidence of any possible side effects or the absence thereof. Companies need to document and present findings related to side effects.
Regulatory Compliance
Evaluation Description
Ensure that the application meets relevant regulatory requirements and ethical guidelines.
Methodology
Ensure that the application complies with relevant regulatory requirements and ethical guidelines. Companies must provide documentation of their compliance measures. References to GDPR, HIIPA, MDR, FDA, ISO 13485 and others
Level of Evidence
Evaluation Description
Level of evidence for application development, Level of evidence for application validations
Methodology
Each criterion should be supported with appropriate documentation and evidence to facilitate the certification process.