HIPAA
Impact Of HIPAA On Clinical Trial Conduct
Clinical Trial Conduct
Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval. The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate. It has greatly impacted the conduct of [...]
HIPAA: Clinical Study Conduct When Searching For Patients Lost To Follow-Up
Much information exists about HIPAA–a multifaceted legislation covering the insurance portability and fraud enforcement (accountability) acts. However, the guidance for privacy and security laws are vague, particularly regarding:
Clinical study conduct and searching for patients that have prematurely dropped out and are lost to follow-up
How HIPAA affects long-term follow-up (pharmacovigilance) programs encourage by the FDA for subjects in [...]
FDA Patient Safety News- Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade November 1, 2008
- Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol November 1, 2008
- Recalls and Safety Alerts: Updated Warning on Byetta November 1, 2008
- Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel November 1, 2008
- Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia November 1, 2008
