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:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.

Summary of the HIPAA Security Rule:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.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:
http://www.hhs.gov/ohrp/policy/index.html.

Institutional Review Boards & Assurances:
http://www.hhs.gov/ohrp/assurances/index.html.

HUMAN SUBJECTS—FDA

Clinical Trials:
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm .

Office of Good Clinical Practice:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191

CONSUMER PROTECTION—FEDERAL TRADE COMMISSION

Bureau of Consumer Protection:
http://business.ftc.gov/privacy-and-security

DOCUMENTS

AMR Public Consultation Draft Meeting Summary

EXTERNAL RESOURCES

RFC RESOURCES

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