News & Analysis as of

OCR issues audit protocol and targets over 800 entities—business associates too

The Office for Civil Rights (OCR) has issued its revamped audit protocol for its second phase of auditing covered entities and business associates’ compliance with the HIPAA Privacy, Security and Breach Notification Rules....more

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

HIPAA Audits Coming Your Way – Are You Ready?

The Office of Civil Rights (OCR) of the Department of Health and Human Services has begun Phase 2 of its audit program under the Health Insurance Portability and Accountability Act (HIPAA). In this phase, OCR will: -...more

Employee Benefits & Executive Compensation Advisory: So You Heard About HIPAA Phase 2 Audits. What Should You Do Now?

As you may have recently read (for example, “HHS/OCR Announces Launch of HIPAA Audit Program Phase 2”), the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has started “Phase 2” of its audit...more

OCR Announces Beginning of 2016 HIPAA Phase 2 Audit Program

The OCR recently announced the beginning of the next phase of the HIPAA Privacy, Security, and Breach Notification Audit Program and indicated that it will review the policies and procedures implemented by covered entities...more

Blog: FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of...more

Be Prepared: Phase 2 HIPAA Audits Set to Begin

On March 21, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), announced the launch of the 2016 Phase 2 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Audit...more

HIPAA Audits Are Here: What to Expect When You are Expecting (an Audit)

The Phase 2 audit program for HIPAA compliance is under way. The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced that it had launched the Phase 2 audits to examine and assess how covered...more

OCR Phase 2 HIPAA Audits Are Here: What to Expect While You’re Expecting (an Audit)

The Phase 2 audit program for HIPAA compliance is under way. The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced that it had launched the Phase 2 audits to examine and assess how covered...more

Phase 2 of HIPAA Audits Is Underway – Covered Entities and Business Associates Beware

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) recently announced that it has started obtaining and verifying entity contact information to identify covered entities and business associates for...more

Developments in Cybersecurity: Privacy Laws, Hacking Beyond Customer Data, and Communicating with Corporate Boards

I. Legal Exposure to Federal and State Privacy Laws - A. Federal Statutes and Enforcement - 1. Federal Trade Commission Act, 15 U.S.C. §§ 41-58 - The Federal Trade Commission (FTC) has emerged as the leading...more

Government Investigations Into Cybersecurity Breaches In Healthcare

In September 2015, a U.S. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), report found that the Office of Civil Rights (OCR), the agency charged with ensuring compliance with the Health...more

Triple-S Management Corporation Will Pay $3.5 Million To Settle Potential HIPAA Violations

On November 30, 2015, the United States Department of Health and Human Services Office for Civil Rights (“OCR”) announced that Triple-S Management Corporation had agreed to pay $3.5 million to settle potential violations of...more

Blog: University of Rochester Medical Center Reaches Agreement to Settle Alleged HIPAA Breach

Last week, the University of Rochester Medical Center (URMC) reached agreement with the New York Office of the Attorney General (NYOAG) to settle alleged violations of the Health Insurance Portability and Accountability Act...more

NAIC Adopts Cybersecurity Bill of Rights

The National Association of Insurance Commissioners (“NAIC”) continued its efforts to advance cybersecurity in the insurance industry when it recently adopted the Cybersecurity Bill of Rights. The Cybersecurity Bill of Rights...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

HIPAA Double Take: What Health Plan Sponsors Need to Know Now

With the onslaught of Affordable Care Act changes, health plan sponsors have much to think about lately. Given the number of other issues affecting them, plan sponsors may feel that HIPAA privacy and security is an issue they...more

The FTC’s Broad Authority and FTC v. Wyndham: Thinking about the Future of Data Privacy Regulations

What makes data privacy law interesting for academics, challenging for lawyers, and frustrating for businesses its shape-shifting structure in the face of rapidly changing technology. The recent change in the invalidation of...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

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach...

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

How to Avoid and Respond to a Cybersecurity Breach

In light of numerous recent data breaches, cybersecurity has emerged as an issue impacting organizations ranging from the local hardware store to the largest multi-national firms in the world. In short, no industry is immune...more

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