Register for the Healthcare Enforcement Compliance Institute

The Healthcare Compliance Institute is scheduled for Oct. 29-Nov. 1 in Washington, DC.

The event will give participants the opportunity to go beyond legal analysis, learn how to implement systems that ensure the law is followed, and gain practical advice from experts in a one-of-a-kind forum where lawyers and compliance officers work together, according to the Health Care Compliance Association.

Some of the topics to be covered include:

  • Are We Ineffective at Assessing Compliance Program Effectiveness or Are Industry and Government Using Different Standards?
  • Handling a Criminal Healthcare Fraud Case
  • Tips and Tools for Mitigating CMS Enforcement Actions
  • Using Data and Statistics to Defend Against Health Care Enforcement
  • Your Company Has Been Served with a Civil Investigative Demand: Now What?
  • Managed Care Fraud Enforcement & Compliance

Register or get more information.

 

 




Healthcare Developer Fined $155 Million for Lying About Compliance

Health records software developer eClinicalWorks has agreed to pay a $155 million to the federal government for civil fraud and kickback charges, according to HIT Consultant.

“Both the government and the whistleblower alleged that eClinicalWorks falsely represented to customers that its EHR [electronic health record] system complied with Meaningful Use requirements,” the publication says. “The settlement marks the first time an EHR vendor is being charged for the truthfulness and accuracy of representations made when seeking government certification of its EHR system and the government applying the federal Anti-Kickback Statute (AKS) law to the promotion and sale of EHR systems.”

The whistleblower alleged the company modified its software to pass testing, without being fully functional. The lawsuit listed several allegations against the company, such as kickbacks for recommendations, and failure to test its software adequately before releasing it.

Read the HIT Consultant article.

 

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How States Are Using the Law to Bring Drug Executives to Heel

Image by Images Money

The generic drug industry has come under fire the last couple of years because of staggering price increases, but now generic drug executives can expect to face tougher legal repercussions, reports MedCity News.

The efforts come in the wake of a 500 percent hike in the generic price of the EpiPen and the 5,400 percent jumpin the price of Daraprim for the treatment of potentially deadly parasite infections, writes Johanna Mayer.

In November 2016, Heritage Pharmaceuticals Inc. sued two of its former executives, Jeffrey Glazer and Jason Malek, using the Racketeer Influenced and Corrupt Organizations Act (RICO). And in December 20 states sued six companies, including Heritage, after a major antitrust investigation by the state of Connecticut.

“Experts predict that these diverse types of lawsuits could ignite a legal domino effect,” Mayer writes. “They also suspect that, as cases like these develop, they’ll expand to touch multiple prongs of the pharmaceutical industry, such as wholesale manufacturers and pharmacies.”

Read the MedCity News article.

 

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2016 HIPAA Year in Review: Audits, Fines, and Enforcement Trends

HIPAACompliancy Group will present a complimentary webinar examining the major breaches and fines that made 2016 the most expensive year on record for HIPAA fines and enforcement.

The event will be Wednesday, Jan. 25, at 2 p.m. Eastern time.

HIPAA experts at Compliancy Group will analyze the causes of these breaches, the reasons for these substantial fines (almost $24 million in total), trends in compliance, and what to expect from OCR investigations in 2017.

Register for the webinar.

 

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Actiance Announces Compliance Platform for Healthcare, Pharmaceutical Industries

Actiance, a provider in communications compliance, archiving, and analytics, has announced the Actiance Platform for the healthcare and pharmaceutical industries.

“Actiance’s next-generation, cloud-based, unified platform addresses new and existing regulatory retention and security and privacy requirements, while reducing the risk and expense of costly eDiscovery and compliance activities,” the company said in a release. “With the Actiance Platform for the healthcare and pharmaceutical industries, organizations can embrace new communications channels while protecting data and ensuring compliance.”

The release continues:

Similar to financial services, the healthcare and pharmaceutical industries are highly regulated and highly litigious. The introduction of new regulations, constant changes to existing protocols, and the explosion of collaboration technology has necessitated healthcare and pharmaceutical companies to update their information management strategies. Regulations, including the 2009 American Recovery and Reinvestment Act (ARRA), the 2013 HIPAA Omnibus Final Rule, the Affordable Care Act (ACA), and the Physician Payment Sunshine Act final rule (42 CFR Parts 402 and 403), govern processes like Electronic Health Record (EHR) adoption, Centers for Medicare and Medicaid Services (CMS) reimbursement, and document retention and management for everything from drug research and development to sales and marketing. Innovations, such as telemedicine and doctor-patient chat, led to laws for Protected Health Information (PHI) and Electronically Stored Information (ESI).

“Patients are taking greater control of healthcare decisions and increasingly demand real-time communications across new channels such as Skype and social media. However, due to regulatory and legal requirements associated with health-related data, the healthcare industry has been slow to respond. With the strain of new channels and huge increase in health data, existing record retention systems originally designed for email capture are reaching their breaking points,” Kailash Ambwani, CEO, Actiance. “The Actiance Platform empowers healthcare and pharmaceutical organizations to meet the needs of today’s patients without worrying about regulatory compliance. This solution is another step in the right direction as healthcare decision makers grapple with the growing demand for infrastructure that meets their needs and increased regulations.”

As new communications channels and networks become available to the healthcare and pharmaceutical industries, records management responsibilities become even more critical. Implementing new communications and social channels without the necessary safeguards and processes exposes firms to non-compliance with industry regulations, potential litigation, and an increased threat of security breaches and data leakage. Organizations risk steep fines and reputational damage without the proper processes, procedures, and technology in place to help manage these complex requirements.

The Actiance Platform for the healthcare and pharmaceutical industries provides:
A single point of control and security for regulated structured and unstructured content, with context, from a variety of sources, in real-time;
The ability to automatically meet regulatory compliance, data security, retention and disposition requirements for more than 70 communications channels;
Cost-effective and quick responses to eDiscovery requests, without impacting employees;
Access to employee identities and profiles maintained across enterprise and public social channels, including first-degree connections;
Increased employee productivity through automated capture, policy management, and archiving of various communications channels in one data repository;
Effective early case assessment with access to the complete archive of all relevant communications;
Automatic classification and tagging of Title 21 CFR Part 11 records based on custom lexicons; and,
Ensured compliance with FDA social media use guidelines by pharmaceutical sales and marketing departments

To learn more about the Actiance Platform, download our healthcare and pharmaceutical white papers.

Additional Information
Stay up to date with Actiance: http://www.actiance.com/blog
Become a fan of Actiance: http://www.facebook.com/actiance
Follow Actiance on Twitter: http://www.twitter.com/actiance

About Actiance
Actiance is the leader in communications compliance, archiving, and analytics. We provide compliance across the broadest set of communications and social channels with insights on what’s being captured. Actiance customers manage over 500 million daily conversations across 70 channels and growing. Customers include the top 10 U.S., top 5 Canadian and top 8 European and top 3 Asian banks. The Actiance advantage is customers stay ahead of compliance and uncover patterns and relationships hidden within their data. Learn more at www.actiance.com.

Actiance headquarters are in Redwood City, California. For more information, visit http://www.actiance.com or call 1-888-349-3223.