Registry
Medication
Diagnostic / Treatement
Digital Diagnostic / Treatement
AI-Supported Diagnostic / Treatement
FemTech
MaleTech
EQUAL CARE® Certification
Digital Diagnostic / Treatement
Evaluation Criteria
Evaluation Items
Evaluation Description
Methodology
Study Representation
Evaluation Description
Sufficient gender representation in comparison to prevalence in the population present in foundational research.
Methodology
Ensure that foundational research includes a gender representation that reflects the prevalence in the population. Companies must provide data demonstrating this balance in their studies. Deviation up to 25 percentage point will be accepted since exact recruitment can be associated with disproportional efforts in resource and time.
Efficacy / Accuracy
Evaluation Description
Gender-segregated data efficacy.
Methodology
Ensure that efficacy data is segregated by gender. Companies must provide evidence showing the effectiveness of their application for different genders, demonstrating that it performs well across these groups.
Functionality
Evaluation Description
Functionality accounts for gender-specific needs as input variables and generates output accordingly for prevention, diagnostics and treatment.
Methodology
The application must account for gender-specific needs by incorporating them as input variables. It should generate appropriate outputs for prevention, diagnostics, and treatment based on these gender-specific inputs. Companies need to provide documentation of how their application addresses these needs.
Personalization
Evaluation Description
Functionality accounts for further personalized needs as input variables and generates output accordingly for prevention, diagnostics and treatment.
Methodology
If the application supports further personalization by incorporating individual user needs as input variables, it should generate tailored outputs for prevention, diagnostics, and treatment based on these personalized inputs. Companies must demonstrate how their application personalizes care and provides documentation of these capabilities.
Accessibility
Evaluation Description
Ensure all users, including those with disabilities, can effectively perceive, understand, navigate, and interact with the digital prevention/diagnostics/treatment. 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
Appropriate level evidence to facilitate the certification process.