Compliance Dept. of Health and Human Services

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
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Free HIPAA Help

Health care providers, health plans, business associates, and other entities affected by the federal HIPAA privacy and security regulations are quickly running out of excuses for not having a robust HIPAA compliance program...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

Hospital Executive Indicted for Allegedly Lying about Meaningful Use of Electronic Health Records

A hospital executive was recently indicted for allegedly submitting a false attestation regarding a hospital’s “meaningful use” of electronic health records (“EHR”) technology through the Medicare EHR incentive program. This...more

DHHS Gearing Up to Begin HIPAA Audits of Business Associates

The office of US Department of Health and Human Services Secretary Kathleen Sebelius recentlyannounced plans to perform "pre-audit" HIPAA compliance surveys of 800 Covered Entities and 400 Business Associates. Under the...more

HHS Reports First HIPAA Settlement with a County Government

According to a HHS press release issued last Friday, Skagit County, Washington, has agreed to a $215,000 settlement with the agency to resolve allegations that the county’s HIPAA compliance program was deficient. The Skagit...more

HIPAA Audits Set to Begin in 2014: Another Enforcement Mechanism for HIPAA Compliance

The Department of Health and Human Services (HHS) is expected to launch its long-awaited HIPAA audit program sometime in 2014. The audit program will be run by HHS’ Office of Civil Rights (OCR), which is likely eager to get...more

HIPAA Housekeeping - Don't Forget Your Annual Report of Small Breaches

If you are a "covered entity" under the Health Insurance Portability and Accountability Act ("HIPAA") and suffer a breach of protected health information, one of your first reactions should be to count the number of affected...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

The Healthcare Industry And Chief Compliance Officers

The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more

Health Care Self-Disclosure Protocols – Is It Worth It To Self-Report?

In recent years the federal government has aggressively investigated and prosecuted pharmaceutical companies and health care providers for possible violations of anti-fraud, anti-kickback and other laws. These efforts have...more

Be Prepared – HIPAA Audits are Coming in 2014

Later this year, the Department of Health and Human Services (“DHHS”) is expected to launch its permanent HIPAA Audit Program. The HIPAA Audit Program is authorized under Section 13411 of the HITECH Act, and is designed to...more

Does Your Wellness Plan Need a (Legal) Check-Up?

Wellness plans must comply with complex final regulations that were issued last year by the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”). To help plans from falling off...more

Health Care Enforcement in 2013: A Year in Review

In 2013, the U.S. Department of Justice (“DOJ”), Health and Human Services Office of Inspector General (“HHS-OIG”), and other federal and state agencies continued to aggressively prosecute health care fraud and related...more

Privacy and Security Alert: January 9th, 2014

On December 5, 2013, the Office of Inspector General (OIG) reported on the Office for Civil Rights’ (OCR) compliance as of May 2011 with oversight and enforcement of the Security Rule and compliance with federal cybersecurity...more

It’s Not Enough to Notify: Don’t Forget the Policies, Risk Analyses, and Training

HIPAA compliance ended with a bang in 2013, with the feds issuing the first settlement involving a health provider’s failure to have breach notification policies and procedures in place. On Dec. 24, 2013, the Department of...more

HHS Gives A Thumbs Down For Stolen Thumb Drive

On December 26, 2013, the U.S. Department of Health and Human Services Office for Civil Rights (HHS) announced that it had reached an agreement with a Northeastern dermatology practice to settle potential HIPAA violations...more

OIG Releases Five-Year Strategic Plan – Providers Need To Keep Compliance Focus

The federal government invests significant resources in combating health care fraud and abuse. The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Strategic Plan...more

GAO Examines Effectiveness of Health Care Fraud and Abuse Control Program Activities

The U.S. Government Accountability Office (GAO) recently published a report analyzing the effectiveness of Health Care Fraud and Abuse Control (HCFAC) program activities titled, “Indicators Provide Information on Program...more

HHS-OIG Corporate Integrity Agreements Are Now Aiming at Corporate Directors and Executives

Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more

Health Update -- Oct 23, 2013

Mapping The New Fraud And Abuse Landscape - In an age of increased government scrutiny and enforcement, providers, payers, pharmaceutical companies and medical device manufacturers, along with their business partners,...more

Data Collection Under The Sunshine Act

Data collection requirements under the Physician Payment Sunshine Act commenced August 1, 2013. This provision of the Patient Protection and Affordable Care Act and the corresponding regulations require an entity that is...more

HHS Issues Guidance on Permitted Remuneration for Prescription Refill Reminders in the Absence of Patient Authorization

On September 19, the Health and Human Services Department (HHS) issued guidance on the effect of the January 25, 2013 Final Rule provision about remuneration related to prescription refill reminders and medication adherence...more

OCR Guidance to Address HIPAA Marketing Turmoil

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services (“HHS”) has committed to issuing guidance by September 23rd (the compliance date for...more

New HIPAA Deadline Around the Corner: Be Prepared!

Don’t look now, but another HIPAA deadline is just around the corner. As we noted last month, the deadline is looming for employer-sponsored health benefit plans to come into compliance with U.S. Department of Health...more

3 Weeks Left: Is Your Business Ready for HIPAA Compliance?

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of...more

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