The FDA regulation in 21 CFR Part 11 came into effect on August 20, 1997. It regulates drug makers, medical device manufacturers, biotech companies, biologic developers and other FDA-regulated industries on how companies should handle electronic records and electronic signatures.The regulation does not mandate the use ofRead more →
Archive for the Events Category
Appointment of DPO is mandatory requirement of GDPR compliance. Depending on the volume of personal data and the size of the organization, a in-house DPO or a virtual DPO can be appointed.
EJR 2.0. can help you stay compliant with GDPR compliance through of DIY online Toolkit or by our consulting service. We also offer virtual DPO service.Read more →
Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules requires all healthcare covered entities and their business associates to conduct security risk analysis of their IT infrastructure annually and with any change in process or system. As part of HIPAA rules, all covered entities and their business associates are required to have proper procedure in place to terminate any employees.
Pagosa Springs Medical Center (PSMC) has agreed to pay $111,400 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a substantial corrective action plan to settle potential HIPAA violations
December 8,2018 – Advanced Care Hospitalists PL (ACH) has agreed to pay $500,000 to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) and to adopt a substantial corrective action plan to settle potential violations of the Health Insurance PortabilityRead more →
November 26, 2018-Allergy Associates of Hartford, P.C.(Allergy Associates), has agreed to pay $125,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability andRead more →
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) replaced three quality programs (the Medicare Electronic Health Record (EHR) Incentive program, the Physician Quality Reporting System (PQRS), and the Value-Based Payment Modifier (VM) with the Quality Payment Program. This one program will give Medicare physicians and clinicians a chanceRead more →
Anthem Pays OCR $16 Million in Record HIPAA Settlement Following Largest U.S. Health Data Breach in History October 15, 2018 Anthem, Inc. has agreed to pay $16 million to the U.S. Department of Health and Human Services, Office for Civil RightsRead more →
Unauthorized Disclosure of Patients’ Protected Health Information During “Boston Med” Filming Results in Multiple HIPAA Settlements Totaling $999,000 September 20, 2018 Today, the Department of Health and Human Services, Office for Civil Rights (OCR) announced that it has reached separate settlements with Boston Medical Center (BMC), BrighamRead more →
Deadlines are fast approaching if you plan to submit data for the 2017 Merit-based Incentive Payment System (MIPS) performance period. Don’t wait until the last minute to submit your data. Submit early and often. The two key dates are: • March 16 at 8 pm Eastern time for groupRead more →
Linda Sanches from Office for Civil Rights (OCR), U.S. Department of Health and Human Services, provided much anticipated updates on Phase 2 HIPAA audit activities at the annual HIPAA conference. NIST and the Department of Health and Human Services (HHS), Office for Civil Rights (OCR), co-hosted theRead more →