Healthcare IT Today

AUGUST 21, 2023

billion in 2022, RFID in the global healthcare market is projected to grow at a CAGR of 17.85% from 2023 to 2030. FDA’s Drug Supply Chain Security Act (DSCSA). Its ability to provide real-time information and automate processes has increased its adoption in the healthcare industry. Valued at USD 3.95

HIPAA 84

HIPAA Regulatory Compliance Hospitals FDA 84

Healthcare IT Today

JANUARY 8, 2024

The excitement around new tools took hold of all industries in 2023, and the potential is expansive. It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. There are considerable risks to adoption that may have deep compliance implications.

Pharmaceutical Industry 81

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 81

SQA

OCTOBER 18, 2022

The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. After this date, the CAP’s compliance team will remove non-compliant ads using targeted software, and those who continue to promote it may be referred to the MHRA for further enforcement action. Health Advance Inc.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

APRIL 21, 2023

84075, 2023 WL 2779206 (Nev. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions. The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information).

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59

Drug & Device Law

JANUARY 25, 2024

23-cv-01060-AJB-DDL, 2023 WL 9010545 (S.D. 15, 2023), a California plaintiff alleged that the medical walker he purchased broke, causing him to fall and sustain injury. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. In Rubalcava v. Medline Indus.,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52

Drug & Device Law

JUNE 5, 2023

2023 WL 2565853 (N.D. March 17, 2023), reconsideration denied , 2023 WL 3032063 (N.D. Finally, Defendant argues that Georgia law permits regulatory compliance to generally rebut the high willfulness requirement for punitive damages. 2023 WL 3032063, at *2 (N.D. The Kelley court agreed with the defendant.

FDA 59

FDA Regulatory Compliance Compliance Fraud 59