Legal Discussion

The Role of Adesso for the Provider

The Adesso platform is designed as a clinical decision support (CDS) software m which provides the overall cardiovascular diagnosis and condition with patient-specific recommendations to Healthcare Providers (HCPs) without replacing or directing the HCP’s judgment.

Our CDS software provides evidence-based clinician order sets to choose from, tailored for microvascular disease, high blood pressure, high cholesterol, elevated sugars and to achieve lifestyle behaviors conducive to an overall heart healthy life. It does NOT provide specific follow-up directives that replace the HCP’s judgment.

We are basing our clinical decision making on:

1. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American Colleg of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

2. Call to Action for Cardiovascular Disease in Women: Epidemiology, Awareness, Access, and Delivery of Equitable Health Care: A Presidential Advisory From the American Heart Association

3. Effectiveness-Based Guidelines for the Prevention of Cardiovascular Disease in Women—2011 Update A Guideline From the American Heart Association

4. Summary of Updated Recommendations for Primary Prevention of Cardiovascular Disease in Women: JACC State-of-the-Art Review

5. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association

6. The evolving role of cardiopulmonary exercise testing in ischemic heart disease - state of the art review

7. A practical clinical approach to utilize cardiopulmonary exercise testing in the evaluation and management of coronary artery disease: a primer for cardiologists

CDS software can match patient-specific medical information to reference information (e.g., clinical guidelines), but should NOT provide a patient-specific treatment plan that directs the HCP’s judgment.

In addition, CDS software must enable HCPs to independently review the basis for recommendations, by: identifying the required medical input information with plain language instructions on how inputs should be obtained, their relevance, and data quality requirements; providing a plain language description of the underlying algorithm development and validation that forms the basis for the CDS implementation, including:

1. a summary of the logic or methods relied upon to provide the recommendations (e.g., meta-analysis of clinical studies, statistical modeling);
2. a description of the data relied upon so that an HCP can assess whether the data is representative of their patient population (e.g., relevant sub-groups, disease conditions) and assess if best practices were followed (e.g., independent development and validation datasets);
3. a description of the results from clinical studies conducted to validate the algorithm/recommendations so that an HCP can assess the potential performance and limitations when applied to their patients (e.g., sub-populations with untested or highly variable algorithm performance); and
4. providing the HCP with an output that includes relevant patient-specific information and other knowns/unknowns for consideration (e.g., missing or unexpected input data values) that will enable the HCP to independently review the basis for the recommendations and apply their judgment when making the final decision.