Blog Articles

The Biden administration has unveiled a healthcare cybersecurity concept paper, emphasizing the need for increased funding and authority to address the rising threat of cyberattacks in the healthcare industry. The Department of Health and Human Services (HHS) outlined a plan that includes new Medicare program requirements, hospital incentive programs, and enhanced internal coordination to strengthen cybersecurity.

The Food and Drug Administration (FDA) has faced significant opposition, with over 19,600 comments received during the public comment period for its proposed changes to the oversight of laboratory developed tests (LDTs). Leading the resistance is the American Clinical Laboratory Association (ACLA), submitting a 107-page document expressing “grave concerns” and urging the FDA to withdraw the proposal.

Summary: A recent investigation by KFF Health News and CBS News reveals concerning issues with Profemur artificial hip implants, once lauded for their innovative dual modular necks. These necks, designed to enhance customization in total hip replacement surgeries, have become a significant liability, causing over 750 fractures over the past two decades.

U.S. hospitals are expected to increase capital spending by approximately 9% in 2024, aiming to address the backlog of elective procedures delayed by the COVID-19 pandemic, according to a Baird survey of 38 health system CFOs representing over 600 inpatient facilities. The survey indicates a slowdown in capital spending growth from the 13% jump observed this year.

Summary: In response to a surge in ransomware attacks on the healthcare sector, the White House is collaborating with the Department of Health and Human Services (HHS) to establish minimum cybersecurity standards. Anne Neuberger, deputy national security advisor for cyber and emerging technologies, highlighted the need to address vulnerabilities linked to recent attacks, particularly the CitrixBleed exploit.

The FDA recently issued a warning letter to pharmaceutical company Cipla, citing multiple violations of Current Good Manufacturing Practice (CGMP). The letter highlighted issues at Cipla’s Indian manufacturing facility, particularly concerning the handling of customer complaints, contamination controls, and inadequate oversight of CGMP records.

Summary: The field of laboratory medicine, integral to public health and healthcare, has witnessed significant technological advancements that are reshaping its role in healthcare provision. This review explores recent innovations such as laboratory automation, genomics, mass spectrometry, microfluidics, and electronic tools, emphasizing their impact on omics research. The integration of these technologies with microtechnology and point-of-care testing is contributing to improved patient outcomes and a more patient-centered healthcare approach.

Five years after the Implant Files investigation by the International Consortium of Investigative Journalists (ICIJ), advocates in the U.S., Canada, and India are still urging health regulators to enhance patient safety. The investigation, conducted in collaboration with 58 media partners worldwide, exposed serious flaws in the global medical device industry, highlighting patchwork regulation and oversight gaps. The Implant Files revealed that over a 10-year period in the U.S.

The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.Henry Schein is a distributor of health care products and services with a presence in 32 countries.

These principles aim to establish a consistent governance structure for advancements in healthcare technology. The AMA emphasizes the importance of ethical, equitable, responsible, and transparent AI implementation.