Skip to main content

Use of Protected Health Information

BayBiotech.NET
Protected Health Information or individually identifiable health information relates to the data about demographics, individual’s past, present or future physical or mental health or condition, provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. Individually identifiable health information includes many common identifiers such as name, address, birth date and social security number.

A covered entity (health plan, a health care clearinghouse, or a health care provider) must obtain the individual’s written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule.

Principle of “Minimum Necessary” Use and Disclosure

Principle of “Minimum Necessary” is the central aspect of the privacy rule. Under this principle, it is expected that a reasonable effort must be made to use, disclose, and request only the minimum amount of protected health information needed to accomplish the intended purpose.

However, the minimum necessary standard does not apply to the following:
1.Disclosures to or requests by a health care provider for treatment purposes.
2.Disclosures to the individual who is the subject of the information.
3.Uses or disclosures made pursuant to an individual’s authorization.
4.Uses or disclosures required for compliance with the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification Rules.
5.Disclosures to the Department of Health and Human Services (HHS) when disclosure of information is required under the Privacy Rule for enforcement purposes.
6.Uses or disclosures that are required by other law.


For more information, follow the link: Protection of Human Subjects

Comments

Popular posts from this blog

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...

eCTD Submission Specifications

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum...

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...