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Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of...more

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

Good News: California Extends Its Medical Data Breach Notification Requirement From 5 to 15 Days

On Sept. 18, 2014, California’s governor approved Assembly Bill 1755, extending California’s stringent breach notification deadline for medical information breaches from five business days to 15 business days for clinics,...more

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

California Extends Deadline for Reporting Breaches to the CDPH from 5 to 15 Business Days

On September 18, 2014, California Governor, Jerry Brown, signed Assembly Bill 1755 (“AB1755”) into law, amending breach notification provisions in the California Health and Safety Code applicable to licensed clinics, health...more

Third Quarter 2014: States Expanding Data Breach Notification Requirements

California, Florida, Kentucky, and Iowa have changed their security breach notification requirements in the past few months: California passed legislation effective January 1, 2015, that for the first time, addresses...more

NIST RFI to Solicit Feedback on Cybersecurity Framework Closing: Good Opportunity to Assess Suggestions and Concerns

On Friday, October 10th, an opportunity to submit comments on a Request for Information concerning awareness and implementation of the “Framework for Improving Critical Infrastructure Cybersecurity” closes. Companies of all...more

Blog: FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber...more

FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management

On October 2, 2014, the Food and Drug Administration (“FDA”) released the final version of a guidance document entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As discussed in a...more

Business Associate Compliance With HIPAA: Findings From a Survey of Covered Entities and Business Associates

The delivery of health care – and payment for that care – is a complex endeavor, and health care providers and health plans rely on third parties to help them operate as businesses and fulfill their responsibilities to...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

HIPAA Violation Results in $4.8 Million Settlement: An IT Perspective

In today’s healthcare industry, information technology (“IT”) systems play an ever-expanding role in the success of a medical practice. Medical practitioners consistently juggle e-billing and electronic medical records...more

Starting Oct. 6, Patients Can Access Test Reports Directly From Clinical Laboratories

On Oct. 6, 2014, a final rule issued jointly by the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Office for Civil Rights (OCR) will require all HIPAA-covered labs...more

Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance...more

Blog: OCR Rep Discusses HIPAA Violations, Enforcement Actions, and Upcoming Audit Program

Last week, the National Institute of Standards and Technology (“NIST”), in conjunction with the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”), hosted a conference entitled “Safeguarding Health...more

“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement. Cozen O’Connor...more

“Access Denied” – Understand How Your Electronic Health Records Are Controlled

Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and...more

OCR Issues Guidance on HIPAA and Same-Sex Marriage

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance last Wednesday to help covered entities and business associates understand the privacy implications of the 2013...more

Privacy Tuesday – September 2014

Happy autumnal equinox Home Depot Breach – By the Numbers: - 56 million cards at risk (compare to Target = 40 million) - $62 million in estimated costs (compare to Target =$146 million and...more

Transitional Compliance Period for Business Associate Agreements Expiring September 23, 2014

If they have not already done so, covered entities and business associates have until September 23, 2014, to update their business associate agreements to comply with the January 2013 changes to the Health Insurance...more

Looming HIPAA Deadline: Update Business Associate Agreements by Monday, September 22, 2014

Business associate agreements that have not already been updated as required by the HIPAA Omnibus Rule should be updated by September 22, 2014. The Omnibus Rule changed and added mandatory language for valid business...more

Business Associate Agreement September 22 Deadline; Same Sex Marriage Guidance Released

There are two important updates with respect to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). First, on September 17, 2014, the U.S. Department of Health and Human Services (HHS) issued guidance to...more

HIPAA Omnibus Rule: Deadline Approaching to Update Grandfathered Business Associate Agreements

Although the HIPAA Omnibus Rule (the “Rule”) went into effect nearly 18 months ago, the transition period for bringing business associate agreements into compliance with the Rule’s new requirements will end on September 23,...more

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