Business and Compliance Concerns

1.0 Regulatory Compliance

1.01 FDA Requirements

Clinical Decision Support Software. Draft Guidance for Industry and Food and Drug Administration Staff. September 27, 2019

A software function is considered CDS, for the purposes of this guidance, if it meets the following:

• Not intended to acquire, process, or analyze [criterion (1)];

• Intended for the purpose of displaying, analyzing, or printing medical information

• [criterion (2)]; and

• Intended for the purpose of supporting or providing recommendations [part of criterion 3]

 CDS (as defined above) is not a device when the HCP can independently review the basis for the recommendation. Thus, for the purposes of this guidance, CDS that meets all parts of the section 520(o)(1)(E) criteria is Non-Device CDS. If CDS fails to meet part of criterion (3) and/or all of criterion (4) then it is Device CDS. 

 "Can the user independently review the basis?" ask whether the function is intended for the purpose of enabling the user to independently review the basis for the recommendations so that it is not the intent that the user rely primarily on any such recommendation (part of criterion (4)).

 1.02 EU Regulations (CE)

Requires compliance as for pharmaceuticals or medical devices. 

2.0 Insurance

2.01 Insurance Required for Decision Support Software

types of insurance

red flags for insurance companies: prescriptive content

3.0 Legal Concerns

3.01 Liability

3.02 Liability and Model Modification

liability for models modified by other users

3.03 Intellectual Property and Copyright

3.04 HIPAA

HIPAA compliance is a major concern for providers. They are often unwilling to connect to resources not under their direct control.

One option is to embed services within the client environment.

Another is to provide each patient with a unique identification code.

3.05 Disclaimer

Legal Notices and Disclaimer

All information contained in and produced by the MedCalc 3000 system is provided for educational purposes only. This information should not be used for the diagnosis or treatment of any health problem or disease. THIS INFORMATION IS NOT INTENDED TO REPLACE CLINICAL JUDGMENT OR GUIDE INDIVIDUAL PATIENT CARE IN ANY MANNER. Click here for full notice and disclaimer.

MedCalc 3000 is Copyright © 1998-2011 Foundation Internet Services, LLC

4.0 Economics

4.01 Cost of Authoring

BPM+ authoring can be expensive in time and money, especially when producing a commercial product.

4.02 Return on Investment (ROI)

market demand

4.03 Marketing

4.04 Cost Estimation Worksheet

Platform access

Model programmer or consultant

Content development (including author release time)

System integration

Testing

Legal and administrative review

Maintenance

Support

Marketing