News & Analysis as of

DWT Releases Latest Health Care Breach Charts

Safeguarding patient information is at the core of responsibilities for health care entities under the Health Insurance Portability and Accountability Act (HIPAA). But safeguarding patient information isn’t just a regulatory...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

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

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to...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 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

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

[Webinar] Mobile Device Management for Health Care Organizations and Vendors - Sept. 10th, 10:00am PDT

In this webinar, we will demystify the HIPAA Security Rule and how to apply the administrative, physical, and technical safeguards in a mobile environment. We will discuss key takeaways from the recently released NIST Draft...more

Ask But Don’t Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff’s Treating Physicians

We walked into the Drug and Device Law Rock Climber’s room last night to find her packing for her return to college while the ignored TV blared in the background. Onscreen was a popular cable reality franchise involving...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

FCC Ruling Addresses Robocalls by Health Care Providers

Mintz Levin’s Communications Practice recently released a Communications Advisory discussing a Declaratory Ruling and Order released by the Federal Communications Commission (FCC). The ruling clarified and expanded the reach...more

Proceed With Caution: Does HIPAA Apply to Your Business?

Even if your business is not in the health care industry, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as updated by the Health Information Technology for Economic and Clinical Health Act (HITECH...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - April 2015

In This Issue: - What's at Risk - Who's Peeking Into Your File? - Quality Control Is Lacking - How to Protect Your Health Information - Excerpt from Who's Peeking Into Your File? The Washington Post...more

Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more

What Can You Expect in 2015 Regarding HIPAA Enforcement?

As of earlier this month, 1, 170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009.  An increase in the...more

HIPAA Settlement Continues to Emphasize the Importance of Security Policies and Procedures

A recently announced settlement between Anchorage Community Mental Health (“ACMHS”) and the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”) emphasizes, once again, the importance of compliance with...more

OIG’s New Work Plan Focuses on the Security of Health Information

On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015. The Work Plan summarizes “new and ongoing reviews of activities...more

Pharmacy Liable for Employee’s Illegal Peek at Customer Prescription Records

In what’s being touted as a national precedent, the Indiana Court of Appeals upheld a $1.4 million trial court verdict for a Walgreens customer whose prescription information was leaked by a pharmacist to a third party. This...more

HIPAA Privacy in Emergency Situations

In light of the Ebola outbreak and other events, the U.S. Department of Health and Human Services, Office for Civil Rights, released a bulletin to ensure HIPAA covered entities are aware of the ways in which patient...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

WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014...more

ACOs And Pay for Value … About the Data

It has been over three years since the Centers for Medicare and Medicaid Services (CMS) announced its proposed rule and guidance on the development and implementation of Accountable Care Organizations. About four million...more

Privacy Wednesday

What’s that old saying … “a day late and a dollar short?” Here is our Privacy Monday roundup … on Wednesday. Office for Civil Rights HIPAA Crackdown? The Office for Civil Rights (OCR) — the enforcement arm of...more

Policyholders Face Heightened Scrutiny Under OCR’s New Permanent Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) has notably increased enforcement of compliance with the Health Insurance Portability and Accountability Act (“HIPAA”) and Health Information...more

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