Medical Research Law & Policy Report® Index-Summary

HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

– Appointments, science panel, 191
– Genetics advisory panel not renewed, 645
– Harmonization of regulations and guidance, panel formed, 188

HEALTH CARE REFORM, FEDERAL

– Comparative effectiveness

See LEGISLATION, FEDERAL, HR 3590, HR 4872

– Effective compliance by medical research organizations, 423
– Outline of reform law provisions, CRS report, 658
– Outlook 2010, 5
– Patient-centered research board, 614

HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH (HITECH) ACT

– Effect of reporting requirements on research, 292
– HIPPA changes, 669; BNA Insights, 736

HEALTH INSURANCE

– Autism therapy coverage denial (E.D. Tenn.), 135
– Experimental surgery

– – Cancer, coverage denial (D. Or.), 399
– – Laser surgery coverage denial (N.J. Super. Ct.), 553

– Spinal surgery coverage (Mich. Ct. App.), 81

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

– De-identification tester, 53
– HITECH changes, 669; BNA Insights, 736
– Informed consent, proposed changes, 441; agency support, 702
– Privacy rule

– – Business associates, HHS proposed rule imminent, 250
– – Enforcement by HHS civil rights office announced, 250
– – Final rules expected, 669
– – Protecting privacy, BNA Insights, 671
– – UCLA researcher sentencing (C.D. Cal.), 288

HHS

See HEALTH AND HUMAN SERVICES DEPARTMENT (HHS)

HIPAA

See HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

HITECH ACT

See HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH (HITECH) ACT

HUMAN SUBJECT PROTECTION

– Assessing risks, 657
– Cold War experiments suit (N.D. Cal.), 648
– Columbia Univ. PET center, 459
– Community hospitals, 462
– Compliance oversight cases decline, 797
– Contraception requirement at issue, 620
– Data retention, OHRP guidance, 619
– Decisionally impaired research subjects

See INFORMED CONSENT

– Evidence-based human research programs, 259
– FAQ from OHRP, 653
– Federalwide Assurance draft changes, 701; expected in May 2011, 800
– Flexibility in OHRP rules, 93
– Guatemala syphilis study, 607; findings recounted, 687; comments from CDC and NIH, 724; reexamination of rules, 749
– Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative, 625
– Improvement, 2010 OHRP policy, 9
– Investigator disqualification, FDA guidance, 386
– IRBs

See INSTITUTIONAL REVIEW BOARDS (IRBs)

– N.Y.C. health worker retaliation suit (N.Y. Sup. Ct.), 663
– “Noninvasive procedure,” clarification from OHRP, 656
– OMB advisor comments, 800
– Peer review data, federal privilege (D. Del.), 338
– Pesticide study subjects, EPA rule, 613
– Quality improvement initiatives oversight, 370
– Russia, health insurance requirement, 625
– Stricter rules at EPA (2nd Cir.), 409
– Students who fail to show up for research appointments, penalties, 50
– Survey of protection programs, 402
– Univ. of Miami halts cancer study, 566
– VA quality indicators, 801
– Veterans human experimentation suit against CIA, DOD, Army (N.D. Cal.), 57
– Va. rules, 180
– YouTube posting by OHRP, 456