Health Information Technologies Data Security

News & Analysis as of

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying...more

International Life Sciences Data Transfers After Schrems

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

OIG Report Finds CMS’s MIDAS System Needs Improvement in Information Security Controls

On September 14, 2015, the OIG released a Public Summary Report finding that although CMS had implemented controls to secure the Multidimensional Insurance Data Analytics System (MIDAS) and consumer personally identifiable...more

OIG Calls for Stronger HIPAA Compliance Efforts

The OIG has issued two reports calling for stronger ONC oversight of covered entity compliance with HIPAA standards. In the first report, “OCR Should Strengthen Its Oversight of Covered Entities’ Compliance with the HIPAA...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Clinically Integrated Networks: Privacy and Security Concerns with Sharing Data

The Centers for Medicare & Medicaid Services (CMS) is changing reimbursement methodologies for healthcare providers from a fee-for-service model to a value-based model. Healthcare providers are responding to the changing...more

NIST Releases Draft Cybersecurity Practice Guide For Electronic Health Records

On July 22, the National Cybersecurity Center of Excellence (“NCCoE”), a U.S. government organization formed in 2012 within the National Institute of Standards and Technology (“NIST”), released a draft Cybersecurity Practice...more

New NIST Guide Advises Healthcare Companies on Securing Patient Health Information on Mobile Devices

In response to a growing demand for cybersecurity guidance in the health care industry, the National Institute of Standards and Technology (NIST), through its National Cybersecurity Center of Excellence, recently published a...more

HIPAA Settlement Regarding Use of Internet Applications

On July 10, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton, Massachusetts, regarding potential...more

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