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The Ultimate GMP
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Regulatory

Technology Trends & News
The HITECH Act for Medical Records: Definition and Compliance
bgo logo 15 May 2024 - 12 min read

The HITECH Act for Medical Records: Definition and Compliance

Healthcare technologyRegulatory

The HITECH Act, short for Health Information Technology for Economic and Clinical Health Act, established in 2009, revolutionizes healthcare by…

Health Information Exchange (HIE): Interoperability and Software
xtatic logo green 16 Feb 2024 - 7 min read

Health Information Exchange (HIE): Interoperability and Software

Healthcare technologyRegulatory

Health information exchange (HIE) is an essential component in the healthcare sector, fundamentally concerned with the electronic movement of healthcare…

Comprehensive Overview: FDA's DTx Approvals in 2023
xtatic logo green 15 Feb 2024 - 12 min read

Comprehensive Overview: FDA’s DTx Approvals in 2023

Healthcare technologyRegulatory

The Food and Drugs Association (FDA) has approved 50% more Digital Therapeutics (DTx) than in 2023 compared to the previous…

Scientist watching a report.
xtatic logo green 08 Feb 2024 - 7 min read

Good Clinical Practice (GCP): Software and Compliance

Regulatory

Good Clinical Practice (GCP) serves as a global benchmark for quality standards in clinical trials involving human subjects. Governments adopt…

Good Pharmacovigilance Practice (GVP): Definition and Compliance
bgo logo 06 Feb 2024 - 13 min read

Good Pharmacovigilance Practice (GVP): Definition and Compliance

Regulatory

Drug development is becoming more global and the need for standardized safety monitoring practices is undeniable. The increased complexity of…

21st Century Cures Act: Software and Compliance
XTATIC HEALTH 01 Feb 2024 - 15 min read

21st Century Cures Act: Software and Compliance

Regulatory

Passed in 2016, the 21st Century Cures Act (The Cures Act) (1) introduced changes intended to increase medical research funding…

Clinical Trial Phases: The Full Guide
xtatic logo green 31 Jan 2024 - 10 min read

Clinical Trial Phases: The Full Guide

Regulatory

Clinical trials are a process in the healthcare world that has been happening for a long time. They play an…

Good Laboratory Practice thumb
XTATIC HEALTH 29 Jan 2024 - 7 min read

Good Laboratory Practice (GLP): Definition and Compliance

Regulatory

New and advanced drug research has been carried out more and more in recent years because of the constant advancement…

Adapting to Change: How New Medical Device Regulations are Impacting the Health Tech Industry?
bgo logo 03 Jan 2024 - 7 min read

Adapting to Change: How New Medical Device Regulations are Impacting the Health Tech Industry?

Regulatory

The regulations for medical devices are constantly changing because they reflect ongoing innovations and safety standards. These changes have significant…

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