Remove 2002 Remove Governance Remove Hospitals Remove Licensing
article thumbnail

Interview: Caroline Cook, Privacy Consultant, GDH Government Consulting Services

HIPAA Journal

Caroline Cook, Privacy Consultant, GDH Government Consulting Services, has shared her thoughts. As a teenager, I volunteered in hospitals and nursing homes. That led to my serving as the Privacy Officer for the hospital beginning with the implementation of the Privacy Rule. I’ve worked in healthcare for over 30 years.

article thumbnail

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice.

FDA 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary 1 | Monthly Update 2021

SQA

in Brampton, Ontario, has been selling personal protective equipment (PPE), including gowns, masks, and gloves, via social media and websites such as Kijiji without the required Medical Device Establishment License (MDEL) from Health Canada. Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.)

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. The MHRA has received reports of a very small number of people who have been hospitalized after using potentially fake pens. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 52
article thumbnail

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. Sharp Memorial Hospital , 264 Cal. Sharp Memorial Hospital, Inc. , at 1291-93 (construing 19 U.S.C. Digital files were not “articles,” which must be “material things.” at 1291-92. at 1293-94.