Medical Research Law & Policy Report® Index-Summary

E-HEALTH

– Breach notification, HHS issues interim final rule, 587
– Challenges and benefits of electronic health records outlined, 395
– La. electronic health records loan program bill signed, 531
– Standards for IT, In Brief, 431

ENFORCEMENT POLICY

– Academic medical centers, FDA crackdown may create opportunities, 98
– Conflicts of interest

See CONFLICTS OF INTEREST

– Federal Register format, In Brief, 711
– HIPAA privacy rule

See HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

– Pfizer to share data with EPA, 367
– Recent administrative actions, chart, 27; 61; 94; 131; 166; 210; 251; 288; 335; 378; 406; 436; 467; 501; 538; 569; 597; 625; 685; 717
– Registering clinical trials, enforcement of compliance planned without federal rule, 715
– Shorter response times and more inspections expected from FDA, 595
– Unsafe drugs, medical devices, and food products, FDA enforcement increase predicted, 340

ENVIRONMENTAL PROTECTION

– Nanotechnology

– – Limited participation in EPA program reported, 51
– – Research strategy issued by EPA, 674

– Toxicogenomic data studied by EPA, 399

ERISA

– Autism therapy, equitable relief denied (E.D. Mich.), 186

EUROPEAN UNION (EU)

– Animal testing

– – Compliance, more animals predicted, higher costs estimated, 588
– – Overhaul of testing regime planned, 365
– – Unneeded testing reviewed, 563; agency issues clarification, 672

– Clinical trials draft guidance issued, 487
– Good Clinical Practices Initiative, FDA reaches agreement with EU agency, 519
– R&D, EU signs off on public-private partnership projects, 397

EXPERIMENTAL TREATMENTS

– Clinical trials

See CLINICAL TRIALS

– Medical monitoring claim over unapproved experimental implant may proceed (E.D. Pa.), 110

EXPERT WITNESSES

– Cornell false claims suit, one defense expert excluded (S.D.N.Y.), 60