HIT Consultant

MAY 9, 2022

With mountains of paperwork generated every year, achieving complete patient privacy and 100 percent compliance can be difficult. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance. The PDF format also integrates easily into EHR platforms.

FDA 98

FDA COVID-19 Public Health Compliance 98

SQA

JUNE 10, 2021

183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices. The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Healthcare IT News - Telehealth

AUGUST 19, 2020

AccessHealth’s licensed chemical dependency counselors are integrated within the medical adult clinics. In 2017, AccessHealth set goals that were modeled after the Department of Health and Human Service’s Healthy People 2020 Program. Currently, there is a 96% overall compliance rate.

COVID-19 173

COVID-19 Telemedicine Compliance HIPAA 173

Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. Sectoral US Laws In the U.S.,

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40