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HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA)established national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. All clinical trial data and activities performed by covered entities must comply with HIPAA regulations.
Confidentiality
  1. What do companies do with respect to confidentiality by subjects on a trial?
    No company attempts to obtain confidentiality agreements from patients, and investigators are not asked to do this.
  2. Are there any guidelines or legal information available on the release of patient medical records or information to CRO for the purposes of identifying potential study patients?
    The investigator has a responsibility according to ICH GCP Guideline E6 section 4.2.1 "to demonstrate a potential for recruiting…subjects" but this does not mean providing personal patient information or medical records. The ICH guidelines covering confidentiality indicate that medical records should not be released to companies for such purposes. In addition, the sponsor company should not have access to the patient’s medical records to be able to release them to a third party.
  		 

Opinion Poll

As per CDSCO-guidance for industry, which form is required Common Submission for Import Licence of Medical Devices in India?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
International Training course in Pharmacovigilance (20/05/13)
19th Asian Congress of Surgery & 1st SingHealth Surgical Congres (18/07/13)
22nd Annual ISAP Meeting (11/10/13)
17th World Congress of Pharmacology [WCP 2014] (13/07/14)

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