Archive for the Events Category

FDA CFR Part 11 Compliance and Benefits

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 of

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Data Protection Officer (DPO) and GDPR Compliance

Data Protection Officer (DPO) and GDPR Compliance

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.

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Colorado hospital failed to terminate former employee’s access to ePHI

Colorado hospital failed to terminate former employee’s access to ePHI

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

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Florida contractor physicians’ group shares protected health information with unknown vendor without a business associate agreement

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 Portability

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Allergy practice pays $125,000 to settle doctor’s disclosure of patient information to a reporter

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 and

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Security Risk Analysis for 2018 MACRA/MIPA Reporting

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 chance

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Unauthorized Disclosure of Patients’ Protected Health Information

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), Brigham

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10 Things to Do and Know for MIPS Reporting Deadlines

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 group

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Update on HIPAA Phase 2 Audits from HIPAA Conference 2017

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 the

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