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glossary Concepts Regulations - Healthcare

medical healthcare

Healthcare has a very detailed and strict regulations.

These are mostly the same as the still growing regulations as with commercial business. A lot is added to as this is a dedicated domain.


papers Health Insurance Portability and Accountability Act Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform.
The Final Rule on Security Standards was issued on February 20, 2003. It took effect on April 21, 2003 with a compliance date of April 21, 2005 for most covered entities and April 21, 2006 for "small plans". The Security Rule complements the Privacy Rule.

Hipaa.com The great thing about HIPAA is that it reflects a move away from cumbersome paper records and an increased emphasis on the security and privacy of health data. But the magnitude of the complex changes it requires can sometimes be overwhelming for healthcare providers, compliance officers and other affected professionals.

papers The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

FDA is related to HHS A lot of information and regulations.

Title 21 CFR Part 11
papers Title 21 CFR Part 11 Title 21 CFR Part 11 of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures.

Europena Part 11

papers The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.

believe cdisc.org CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.

The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, 501(c)(3) non-profit standards developing organization (SDO) that has been working through productive, consensus-based collaborative teams, since its formation in 1997, to develop global standards and innovations to streamline medical research and ensure a link with healthcare.

CDISC mainly consists of the following:


papers De ‘Continuity of Care Record’ CCR/CCD (CCR) is een standaard die de zorgverlener helpt bij de overdracht van informatie aan een collega. Bij CCR gaat het om een samenvatting van de gezondheidssituatie van de patiënt. Het Continuity of Care Document (CCD) is de feitelijke brief of het document waar de informatie in staat en geeft een overzichtelijk beeld weer, geordend volgens de architectuur van de HL7-standaard. (bron nictiz.nl


papers IHE IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information.
ihe-nl.org The dutch site of it.

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Measuring - Standards

BMI index age adjust
SAS Program for the CDC Growth Charts (CDC) Growth Charts (CDC - US based)

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standars to software

Open Ehr is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs). In openEHR, all health data for a person is stored in a "one lifetime", vendor-independent, person-centred EHR. The openEHR specification is not concerned with the exchange of data between EHR-systems as this is the primary focus of other standards such as EN 13606 and HL7.
HL7 Health Level Seven (HL7), is a non-profit organization involved in the development of international healthcare informatics interoperability standards. "HL7" also refers to some of the specific standards created by the organization
EN 13606
EN 13606 The overall goal of this Health informatics - Electronic Health Record Communication (EN 13606) European Standard is to define a rigorous and stable information architecture for communicating part or all of the Electronic Health Record (EHR) of a single subject of care (patient).


Suppliers of tools EDC/CDM

rave (medidata )


Blogs and ohter notes

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© 2012 J.A.Karman (8 mar 2013)