Examination of Clinical Trial Costs and Barriers for Drug Development. 4.5.3 Regulations for Multiple Jurisdictions
In addition to the federal regulations listed above, there are also state and local regulations to comply with, and the requirements may be different for each location in multi-site trials. Companies conducting trials at sites in the European Union (EU) (or other countries) are also regulated by the European Commission/EU Clinical Trials Directive
Federal Trade Commission. “Data Brokers: A Call for Transparency and Accountability.” Washington, DC: Federal Trade Commission. Available at [ http://www.ftc.gov/system/files/documents/reports/data-brokers-call-tran... . May 2014.
Minimizing Disclosure Risk in HHS Open Data Initiatives. 3. Health Insurance Portability and Accountability Act (HIPAA) of 1996
HIPAA applies to health plans, clearinghouses, and health care providers. This legislation is often considered the “high water mark” for how entities “balance risks to privacy against valuable uses of information” (Ohm 2010). There are two key regulations that emerged from HIPAA: the Privacy Rule and the Security Rule. a. Standards for
Public use microdata play a critical role in research and policy analysis. Exploratory research and many types of policy analysis do not lend themselves well to the conditions that govern restricted access as described above. The creation of public use data that protect the confidentiality of the subjects begins with de-identification, but dependi
HHS is actively engaged in disseminating information relating to the privacy, confidentiality, and protection of health data through conferences and workshops covering the topics of legal issues, restricted data and restricted access procedures, disclosure risk analysis, and statistical disclosure limitation methods and techniques. For example, HH
Federal agencies have a long history of releasing data to the public, and they also have a legal obligation to protect the confidentiality of the individuals and organizations from which the data were collected. Federal agencies have successfully balanced these two objectives for decades. With the new emphasis on expanding public access to federal
Evaluation of the Strong Cities, Strong Communities (SC2) Teams Pilot: Final Report. 3.5 Summary of Reported Key Accomplishments
While the SC2 teams undertook a vast number of activities, not all activities were completed, and among completed activities only a subset were regarded as key accomplishments by stakeholders interviewed for this study. The evaluation team’s discussions with pilot city stakeholders and team members examined what the SC2 teams were able to accomp
Performance Improvement 2009. Appendix A - Federal Domestic Assistance Programs of the Department of Health and Human Services
Federal Domestic Assistance Programs of the Department of Health and Human Services 
Mission To provide advice on public health and science to the Secretary of Health and Human Services, to provide executive direction to program offices within the Office of Public Health and Science (OPHS), and, at the direction of the Secretary, to coordinate crosscutting public health and science initiatives in the Department. Evaluation Pro
Performance Improvement 2002: Evaluation Activities of the U.S. Department of Health and Human Services is the eighth annual report to Congress summarizing previous fiscal year evaluation efforts. The purpose of this report is to provide Congress with outcome-oriented evaluation findings for the Department's programs, policies, and strategies. It
Performance Improvement 2001. Assessment of State Laws, Regulations and Practices Affecting the Collection and Reporting of Racial and Ethnic Data by Health Insurers and Managed Care Plans
Not having racial and ethnic (r/e) data collected by health insurers and managed care organizations (MCOs) has led to a dearth of r/e data to assess the health status, access to and quality of health services for minorities, as well as the inability to monitor progress towards eliminating racial and ethnic disparities.
Performance Improvement 2001: Evaluation Activities of the U.S. Department of Health and Human Services is the seventh annual report to Congress summarizing previous fiscal year evaluation efforts. The purpose of this report is to provide Congress with evaluative information on the Department's programs, policies, and strategies. It contains brief
OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION MISSION: To provide analytical support and advice to the Secretary on policy development and assist the Secretary with the development and coordination of departmentwide program planning and evaluation activities. Evaluation Program
Performance Improvement 1998 is the third annual report of the U.S. Department of Health and Human Services (HHS) on its evaluation activities. As a report to Congress, it summarizes the findings of HHS evaluations completed in fiscal year (FY) 1997. In that year, HHS agencies produced 155 evaluation reports and supported more than 335 evaluation
Screening and Assessment in TANF\Welfare-to-Work: Ten Important Questions TANF Agencies and Their Partners Should Consider. References
Allen, J.P., M.H. Eckardt, and J. Wallen. Screening for Alcoholism: Techniques and Issues . Public Health Reports 103:586-592, 1988. American Civil Liberties Union. Judge Blocks First-Ever Mandatory Drug Testing of Michigan Welfare Recipients . Press Release. November 10, 1999. American Public Human Services Association. Case Management Def
Screening and Assessment in TANF\Welfare-to-Work: Ten Important Questions TANF Agencies and Their Partners Should Consider. How do Legislation and TANF Policies Provide Incentives to Screen and Assess?
Title II of the ADA of 1990 "is intended to protect qualified individuals with disabilities from discrimination on the basis of disability in the services, programs, or activities of all State and local governments." 8 The ADA defines "disability" as a physical or mental impairment that substantially limits one or more of the major life activitie
Screening and Assessment in TANF\Welfare-to-Work: Ten Important Questions TANF Agencies and Their Partners Should Consider. Question Two: Why should TANF agencies consider screening or assessment?
While a few states have been screening and assessing clients for health conditions, disabilities, and barriers to work for several years, there are a number of reasons why there is a growing interest in identifying and addressing unobserved barriers to employment. The overarching motivation for uncovering barriers is to fulfill the employment obje
Screening and Assessment in TANF\Welfare-to-Work: Local Answers to Difficult Questions. References and Resources
American Public Human Services Association. Charting the Path to Employment: States’ Client Assessment Policies and Practices to Support Welfare Reform . Washington, D.C. June 2001. Derr, Michelle K., Sarah Douglas, and LaDonna Pavetti. Providing Mental Health Services to TANF Recipients: Program Design Choices and Implementation Challenges
Performance Improvement 2006. Racial, Ethnic and Primary Language Data: An Assessment of State Laws, Regulations and Practices Affecting Their Collection and Reporting by Health Insurers and Managed Care Plans
While acknowledging the importance of racial and ethnic (r/e) data collection in identifying r/e disparities in access to and quality of health care, and in monitoring and ensuring progress towards elimination of such disparities, representatives of many health insurers and managed care organizations (MCOs) have not collected such data, due at lea