Generalizing FDA guidance on clinical decision support

Biomedical Instrumentation and Technology

Volumn 46, Issue 6, 2012, Pages 438-442

  Hyman, William A ^a  

^a Texas A M University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALGORITHM; COMPUTER PROGRAM; DECISION SUPPORT SYSTEM; ELECTRONIC MEDICAL RECORD; EXPERT SYSTEM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; HUMAN; IMAGE ANALYSIS; IMAGE PROCESSING; INFORMATION PROCESSING; MEDICAL DEVICE; SHORT SURVEY; WORKFLOW;

COMPUTER SECURITY; CONFIDENTIALITY; DECISION SUPPORT SYSTEMS, CLINICAL; HEALTH RECORDS, PERSONAL; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; PRACTICE GUIDELINES AS TOPIC; RADIOLOGY INFORMATION SYSTEMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84869852148     PISSN: 08998205     EISSN: 19435967     Source Type: Journal    
DOI: 10.2345/0899-8205-46.6.438     Document Type: Short Survey

References (7)

1. CMS. EHR Meaningful Use Overview. Centers for Medicare and Medicaid Services. Available at: www.cms.gov/regulations-and-guidance/legislation/ ehrincentiveprograms/meaningful-use.html. Accessed July 8, 2012.
2. ONC. Clinical Decision Support. Office of the National Coordinator of Health Information Technology. Available at: http://healthit.hhs.gov/portal/ server.pt?open=512&mode=2&cached=true&objid=1218&Pageid=15590. Accessed July 8, 2012.
3. FDA. Guidance for Industry and FDA Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions. Available at: www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm187249.htm?source=govdelivery. Accessed July 6, 2012.
4. FDA. Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. Available at: www.fda.gov/ medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187277.htm? source=govdelivery. Accessed July 7, 2012.
5. FDA. MDDS Rule. Available at: www.fda.gov/medicaldevices/ productsandmedicalprocedures/generalhospitaldevicesandsupplies/ medicaldevicedatasystems/ucm251897.htm. Accessed July 2, 2012.
6. FDA. PMA Approval. Available at: www.fda.gov/medicaldevices/ productsandmedicalprocedures/deviceapprovalsandclearances/recently- approveddevices/ucm289473.htm. Accessed July 2, 2012.
7. FDA. Food and Drug Administration Safety and Innovation Act. Available at: www.gpo.gov/fdsys/pkg/bills-112s3187enr/pdf/bills-112s3187enr.pdf. Accessed Aug. 22, 2012. doi: http://dx.doi.org/10.2345/0899-8205-46.6.438