Important Documents

De Glosario Médico-IT-Administración para Hospitales
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Note: If you want to contribute to this glossary, we invite you to add words and definitions that can help the health innovation community. Please:

  • Add the word and its definition in alphabetical order.
  • Add the source where you got the definition at the bottom of the page and add the number to the end of the new definition.

This is an Initiative from Hacking Health Monterrey


Important Documents

In this section you will find documents that are important for the development of a Health Startup.

  • Cybersecurity
* ISO 27000 [1]
* HIPAA [2] y [3]
  • Ethics
* The Belmont Report [4]
* PROTECTION OF HUMAN SUBJECTS [5]
  • Health Information
* Health IT Legislation and Regulations (HITECH Act) [6] 
  • Medical Devices
* FDA REGISTRATION AND MEDICAL DEVICE LISTINGS [7]
* FDA UNIQUE DEVICE IDENTIFIER (UDI) AND GLOBAL UNIQUE DEVICE IDENTIFIER DATABASE (GUDID) [8]
* One Click Scorecard [9]
* Qualification of Medical Device Development Tools [10]
  • Pharmacovigilance
* FDA DRUGS: Including DRUG ESTABLISHMENT REGISTRATION AND LISTINGS, DRUG LABELING AND INGREDIENT REVIEWS, FDA DRUG MASTER FILES (DMF), DATA UNIVERSAL NUMBERING SYSTEM (D-U-N-S®), SELF-IDENTIFICATION REQUIREMENTS FOR GENERIC DRUG FACILITIES, DRUG COLOR ADDITIVES AND DRUG COLOR BATCH CERTIFICATION, CERTIFICATE OF REGISTRATION ISSUED BY REGISTRAR CORP, and DETENTION WITHOUT PHYSICAL EXAMINATION ("DWPE") ASSISTANCE [11]
  • Research
* Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [12]