News & Analysis as of

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

OCR Releases Information on What Phase 2 HIPAA Audits Will Look Like

The HHS Office for Civil Rights (OCR) recently presented information about the new look of its Phase 2 audit program. The new audits will look little like the old ones, with OCR conducting the audits itself and focusing on...more

New HIPAA Tool Released by the Federal Government – Makes Assessing Risks Easier and It Won’t Cost You a Dime

Do you lie awake at night wondering if you or the health care entity for which you work is complying with the Health Insurance Portability and Accountability Act (“HIPAA”)? If so, you will be happy to hear that a good night’s...more

HHS releases Security Risk Assessment Tool to Help Providers with HIPAA Compliance

In collaboration with the HHS Office for Civil Rights, the Office of the National Coordinator for Health Information Technology released a new tool designed to help practices conduct and document a comprehensive assessment to...more

HIPAA Security Risk Assessment Tool Released by HHS

HIPAA security risk assessment (SRA) tool was recently made available through HHS. The tool was developed as a collaborative effort between the HHS Office of the National Coordinator for Health Information Technology (ONC),...more

New Resource Available to Providers for HIPAA Security Rule Compliance

On March 28, 2014, the U.S. Department of Health and Human Services (“HHS”) announced the release of a security risk assessment (“SRA”) tool to assist small- to mid-sized providers in conducting risk assessments of their...more

HHS's New Security Risk Tool for HIPAA Compliance

On March 28, 2014, the HHS Office of the National Coordinator for Health Information Technology (ONC), in conjunction with the HHS Office for Civil Rights (OCR), released a Security Risk Assessment tool (SRA tool) to assist...more

Government Releases New Tool to Assist with HIPAA Security Rule Risk Assessments

The Office of Civil Rights (OCR), in collaboration with the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Office of General Counsel (OGC), released a new security risk assessment (SRA)...more

Trustee Alert – HIPAA EDI Certification Proposed Rule

The Trust's business associates who perform electronic transactions on its behalf are required to follow certain HIPAA standards and operating rules. A recently published proposed rule introduces a new requirement to submit...more

Counties Beware – Your Governmental Status Does Not Protect You from Liability for a HIPAA Breach

As a county government, you may think that you have the protection of sovereign immunity and protection from other governments penalizing you. Your status does not protect you. The Department of Health and Human Services...more

HHS Settlement: Reminder That HIPAA Applies To Local Governments Big And Small

The U.S. Department of Health and Human Services Office for Civil Rights (HHS) recently announced that it had reached an agreement with Skagit County, Washington to settle potential HIPAA violations involving the County...more

Privacy And Data Security For Life Sciences And Health Care Companies

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more

Department Of Health And Human Services Office Of Inspector General's FY 2014 Work Plan Identifies Security Of EHR Technology As...

On January 31, 2014, the U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") released its annual work plan. Not surprisingly, issues relating to Electronic Health Records ("EHRs")...more

Data Breach Wall of Shame: 2013's Highlights and Lessons

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.” In 2013, 160 large data breaches were reported to...more

HHS Announces First HIPAA Settlement Based on Lack of Breach Notification Policies and Procedures

The Department of Health and Human Services (HHS) recently announced the first settlement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) based on violations of the law's privacy, security,...more

Looking At The Past To Predict The Future Of HIPAA/HITECH Enforcement

2013 was a busy year for the Department of Health and Human Services (“HHS”). On January 17, 2013, HHS issued its Final Omnibus Rule, substantially modifying the Privacy, Security and Enforcement Rules promulgated by the...more

Extension of and Modification to Regulatory Protections for Donated EHR

In the December 27, 2013 edition of the Federal Register, the Office of Inspector General (“OIG”) and Centers for Medicare and Medicaid Services (“CMS”), both within the U.S. Department of Health and Human Services (“HHS”),...more

Providers: Prepare Your Breach Notification Policy!

On December 26, 2013, Adult & Pediatric Dermatology, a dermatology practice located in Massachusetts, agreed to pay a $150,000 fine after it lost an unencrypted thumb drive containing over 2,000 patients’ health records, and...more

Medical practice agrees to payment due to HIPAA data breach

One day after Christmas, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced that a Massachusetts-based dermatology practice (Practice) agreed to a $150,000 payment and entered into a...more

Texas to Launch Nation's First Privacy and Security Certification "Safe Harbor"

The Texas Health Services Authority (THSA) recently announced its selection of the Health Information Trust Alliance (HITRUST) Common Security Framework (CSF), the most widely adopted information privacy and security...more

OCR Releases Model Notices of Privacy Practices

Under the Privacy Rule, an individual has the right to adequate notice of how a covered entity may use and disclose PHI about the individual, as well as his/her rights and the covered entity’s obligations with respect to that...more

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

It's Never Too Late To Give Guidance: OCR Starts Releasing HIPAA Omnibus Rule Guidance In Anticipation Of September 23 Compliance...

This has been a busy week for the Department of Health and Human Services / Office for Civil Rights (HHS/OCR). It has started releasing guidance on various provisions of the Omnibus HIPAA final rule (the "Final Rule") in...more

Protecting Your Business with Strong Operational Privacy Controls

For decades basic requirements to secure business records have been rooted in various legal silos, from corporate governance to rules of evidence to the discrete privacy rules that govern select technologies. Today, however,...more

HHS States That It Will Issue Guidance On HIPAA Regulation For Prescription Refill Reminders

On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more

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