Entrants are required to identify and address privacy and security issues in their proposed projects and describe specific solutions for meeting them. In addition to complying with appropriate policies, procedures, and protections for data that ensures all privacy requirements and institutional policies are met, use of data should not allow the identification of personally identifiable information from the individual from whom the data was collected.
Entrants are responsible for compliance with all applicable federal, state, local, and institutional laws, regulations, and policies. These may include, but are not limited to, Health Information Portability and Accountability Act (HIPAA) protections, HHS Protection of Human Subjects regulations, and Food and Drug Administration (FDA) regulations. If approvals (e.g., from an Institutional Review Board) will be required to initiate any activities associated with submission development in the competition, it is recommended that entrants apply for approval at or before that phase’s submission deadline. The following links are intended as a starting point for addressing potentially applicable regulatory requirements but should not be interpreted as a complete list of resources on these issues:
HIPAA
Main link: http://www.hhs.gov/ocr/privacy/index.html.
Summary of the HIPAA Privacy Rule: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html.
Summary of the HIPAA Security Rule: https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html.
Human Subjects—HHS
Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.
Protection of Human Subjects Regulations:http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
Policy & Guidance: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
Institutional Review Boards & Assurances: https://www.hhs.gov/ohrp/irbs-and-assurances.html.
Human Subjects—FDA
Clinical Trials: https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection.
Office of Good Clinical Practice: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials.
Consumer Protection—Federal Trade Commission
Bureau of Consumer Protection: https://www.ftc.gov/business-guidance/privacy-security