Attachment 2 GLOSSARY.pdf

Attachment 2 – Glossary of Terms & References

Term Definition

Ad-hoc Services Additional analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools.

Aggregated Data Any data that has been re-formatted or derived from the original data report or data set, e.g., raw data. Aggregated data are typically presented in tables, charts, and text.

Commercially Available

The data resource, or access to it, is available for sale or has been sold to the general public as of June 1, 2010 (Note: The FDA does not intend to use this solicitation to initiate or complete development of a resource.)

Currently Existing The data chosen for this award must be a commercially available product at the time of the proposal. The FDA does not intend to use this solicitation to initiate or complete development of a resource.

Dataset Adjustments and Corrections

Restatements of or modifications made to previously released data.

Data Dictionary A document that describes the information available in the data resource. This information shall minimally include field or variable name, description, definition (including business rules for computed fields and missing data), and allowed values. All fields or variables in the data resource should be included in this document.

Dataset Extract A file of data necessary to address a particular study question. Each dataset extract may contain multiple USC classes, markets or years of data

Desktop Authorized FDA personnel should be able to access the data from their own computers (i.e., no special or customized hardware should be required for access).

Direct Authorized FDA personnel should be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractor’s part should be necessary. In addition, output that consists of formatted reports only will not be acceptable).

Disclosure Policy The process of providing FDA written authorization to disclose information from this resource in public forums or sharing with third parties on collaborative projects initiated by FDA for public health safety and regulatory purposes. This process shall ensure that the information or data disclosed is accurate and does not violate any of the Offeror’s existing agreements.

Firewall-to- Firewall Virtual Private Network

(VPN)

Secure TCP/IP connection between two firewalls that simulates a local area network. Encryption/decryption and authentication are mandatory for the VPN solution.

Food and Drug Administration Amendments Act

FDAAA 2007

The Food and Drug Administration Amendments Act (FDAAA) of 2007 (H.R. 3580) was signed into law on September 27, 2007 and represented a significant addition to FDA authority. Section 905 of FDAAA directed FDA to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system. The law set a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also required FDA to work closely with partners from public, academic, and private entities. In response, FDA launched the Drug Utilization Initiative to achieve these mandates.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW- 110publ85.pdf https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/Si gnificantAmendmentstotheFDCAct/FoodandDrugAdministrationAm endmentsActof2007/ucm184271.htm

Federal Information Security

The Federal Information Security Management Act of 2002 (FISMA) was https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm184271.htm

Management Act

(FISMA)

passed in 2002 as Title III of the E-Government Act (Public Law No. 107- 347). FISMA requires each federal agency to develop, document, and implement agency-wide programs to provide information security for the operations and assets of the agency, including those provided or managed by other agencies or outside contractors.

Final Data Fully summarized or processed data

Full Disclosure Of data collection, construction, coding and configuration – The FDA shall receive detailed information on how the sample is selected, how data are obtained and cleaned/edited for analysis, how the data was built how variables are defined, and the relationship between variables within the data structure.

Health Insurance Portability and Accountability Act (HIPAA)

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (Public Law No. 104-191) is a federal law that governs: 1) health insurance coverage for workers and their families when they change or lose their jobs; and 2) the establishment of national standards for electronic healthcare data transactions.

https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

HIPAA Privacy Rule

The HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) establishes national standards to protect individuals' medical records and other individual health information and applies to health plans, healthcare clearinghouses, and those healthcare providers that conduct certain healthcare transactions electronically. The Rule requires appropriate safeguards to protect the privacy of individual health information and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization.

Immediate Authorized FDA personnel should be able to access the data whenever needed.

Multi-user Environment

Two or more authorized FDA users should be able to access the data at the same time from different locations.

National Projections

The ability to accurately estimate drug utilization for the U.S. population using the sample captured in the data.

Original Prescribed Product

The original prescribed product as written or indicated by the prescriber.

Outpatient Any place where health care is received without being admitted to the hospital as an inpatient. (NB: Day surgery, ambulatory care centers, and other outpatient services provided by hospitals may be considered to be within the outpatient setting.)

Prescription Drug Product

Any drug approved by the FDA to be dispensed through all pharmacies settings

Project Advisory Group (PAG)

FDA staff designated to serve as an advisory and review body on technical matters during the procurement process.

Projection or Other Appropriate Methodologies

Projection methodology is an algorithm that can be used to reliably and accurately estimate pharmaceutical sales for the U.S. population using the sample captured in the data. Other appropriate methodologies may include, but are not limited to, gathering drug utilization data on the universe of pharmaceutical sales (e.g., a “census” method), which may reduce or eliminate the need for projection. Should a “census” method be chosen, the Contractor shall provide mutually acceptable evidence that the data are adequately representative of pharmaceutical sales data in the U.S.

Raw Data Data in the form obtained from the data access tool which is not further summarized or processed.

Real-time Real-time access refers to doing something while people are watching or waiting. FDA expects The Contractor to provide information on how readily available access to their data will be.

Reliable The projection method used must yield the same or similar results in the same or similar situations (e.g., must be reproducible and repeatable).

Robust In cases where the assumptions underlying the projection or other appropriate methodology are not all met, the results obtained should be the same as in similar situations where all assumptions and conditions are fully met.

Secure At no time will passwords, login, or data be open to inspection or intrusion by unauthorized parties.

Unlimited Authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.

Valid An assessment of how well the projected values reflect what is actually happening in the entire population of interest.