Preliminary Data Extraction on Epic – Key Points from Stacy Smith
- Feasibility Checks Without IRB Approval:
- Residents may perform preliminary data queries in Epic without IRB submission if they are not collecting any patient identifiers.
- Examples include querying aggregate data like:
- Number of patients with a specific ICD code.
- Number of ischemic stroke discharges within 48 hours.
- These types of queries are allowed as long as the data returned is aggregate and non-identifiable.
- When IRB Oversight Is Required:
- If the data extraction involves identifiable information (e.g., race, geography, dates of birth, medical record numbers, service dates), then IRB approval is required.
- Stacy emphasized that the IRB also serves as the privacy board, so any data that could be re-identified must go through IRB review.
- HIPAA Identifiers to Avoid:
- Stacy mentioned the 18 HIPAA identifiers that must not be included in preliminary data extraction without IRB oversight.
- Common pitfalls include:
- Dates of service.
- Extremes of age (e.g., a 95-year-old patient could be considered identifiable).
- Best Practice Recommendation:
- Before starting any proposal or data extraction, residents should consult with Stacy Smith or Julie Bird to ensure feasibility and compliance.
- This helps avoid wasted effort and potential rejection due to incomplete or non-compliant submissions.
18 HIPAA Identifiers to Avoid
- Names
- Geographic subdivisions smaller than a state (e.g., street address, city, county, zip code)
- All elements of dates (except year) directly related to an individual, including:
- Birth date
- Admission date
- Discharge date
- Date of death
- All ages over 89 (unless aggregated into a category like “90 and older”)
- Telephone numbers
- Fax numbers
- Email addresses
- Social Security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate/license numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web URLs
- IP addresses
- Biometric identifiers, including fingerprints and voiceprints
- Full-face photographs and comparable images
- Any other unique identifying number, characteristic, or code
If you’re planning a feasibility query in Epic, make sure the data is fully de-identified and aggregate only.