Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Dot Compliance

JANUARY 14, 2022

Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. Key risk management regulations for Life Sciences companies include: ISO 12485:2016. This internationally recognized standard was revised and published in 2016. Source: [link].

Compliance 52

Compliance FDA Regulatory Compliance Governance 52

HIT Consultant

JANUARY 24, 2022

Are we putting enough safeguards and governance in place for AI-driven decision-making, particularly in areas of automated machine learning? That’s why the theme of a recent FDA-Project Data Sphere Symposium was entitled “The Art of the Possible.” Are humans in the process loop to verify both inputs and outputs of AI predictions?

Governance 98

Governance FDA Doctors COVID-19 98

Healthcare IT Today

MAY 5, 2023

Department of Health and Human Services (HHS) analysis showed Medicare payments for genetic testing quadrupled from 2016 to 2019. The surge in genetic testing claims comes with a rise in fraud, waste and abuse across government and commercial payers. In 2021, a U.S. Common schemes include: Code stacking.

Fraud 62

Fraud Medicare Medicare Overpayments 62

Health Law Advisor

APRIL 26, 2023

FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. During the past several turbulent weeks for the U.S. While the U.S.

FDA 97

FDA Hospitals Governance Compliance 97

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

These standards include but are not limited to the following list and are available at no charge in read-only format: ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk. ISO 13688:2013, Protective clothing – General requirements.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83