Hall Render
OCTOBER 5, 2023
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.
MedTrainer
DECEMBER 7, 2023
State-specific governing bodies, such as the Bureau of Facility Standards , provide oversight with certain standards, adding a layer of complexity to successfully managing healthcare compliance in Idaho. Continue reading this overview for key aspects of healthcare compliance specific to the state of Idaho.
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MedTrainer
NOVEMBER 5, 2023
Colorado, like other states in the United States, has its own set of regulations and requirements that make managing healthcare compliance in Colorado tricky. To effectively manage compliance, healthcare organizations must establish a robust system for monitoring and interpreting these changes and swiftly implement necessary adjustments.
MedTrainer
APRIL 11, 2024
Incident reporting is essential to maintain a healthcare organization’s compliance with state and federal regulations and reveal what are the main types of healthcare incidents. There were 13 recalls during the same period in 2023. MedTrainer offers all the functions listed above in an all-in-one compliance solution.
AIHC
SEPTEMBER 5, 2023
Compliance Considerations for Best Outcomes Written in collaboration with the AIHC Volunteer Education Committee Delivering mental health services via telehealth has increased since the COVID-19 pandemic. This information was published due to the end of the COVID-19 Public Health Emergency (PHE) which began May 12, 2023.
Bill of Health
FEBRUARY 29, 2024
Nepal’s National Parks and Wildlife Conservation Act does not include a provision for the free, prior, and informed consent of Indigenous Peoples as mandated by the Nepal-ratified United Nations Declaration on the Rights of Indigenous Peoples. Nor does the Forest Act 2019 contain provisions to protect the rights of Indigenous Peoples.
SQA
FEBRUARY 15, 2023
Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023. Finalization of the document is planned for 2026.
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