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
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.
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
The General Data Protection Regulation (EU) 2016/679 (“GDPR”) is a regulation in EU law on data protection and privacy for all individuals within the European Union (EU) and the European Economic Area (EEA). GDPR applies to all business in EU countries that works with customers data of EU citizens. The law also addresses the export of personal data outside the
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
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
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
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 Rights
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
The primary purpose of security risk analysis for Meaningful Use/MIPS is to identify key technical vulnerabilities in the electronic Protected Health Information (ePHI) and EHR systems environments. In order to implement appropriate technical controls, eligible professionals and hospitals need to conduct a security risk analysis in accordance