Category: Data Driven Compliance

Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.

Global Transparency Compliance: Getting Your Data in Order is Necessary

Both the U.S. and global transparency requirements call for Life Sciences companies to fulfill certain transaction-level reporting criteria. These requirements include the Sunshine Act, U.S. state laws, and European laws. All of these deem it necessary for transfers of value made by pharma companies to physicians to be tracked and reported to the authorities. The […]

Managing Consent With a Real-Time Database Solution

A major concern for pharma manufacturers in the EU when submitting their spend is that of duplication of data. The reason behind this concern is that of the risk it poses to their reputation and relationship with HCPs. However, duplication of data can be avoided by verifying it with HCPs before making the data public. In […]

FCA Civil Penalties Increased by the Department of Justice Again

The Department of Justice announced on February 3, 2017, that penalties for the False Claims Act (FCA) will be increasing once again, effective immediately. The minimum per-claim penalty will increase from $10, 781 to $10,957 as a pursuant to the 2015 budget bill that calls for annual re-indexing of FCA penalties for inflation. On the […]

Open Payments Systems Become Available for Registration & Data Submission

The Open Payments system is now available for applicable manufacturers and group purchasing organizations (GPOs) to: – Register – Recertify their registration from the previous year – Submit data for the Program Year 2016 – Submit corrected data from previous Program Years (if required) Now that the system is available, all applicable manufacturers and GPOs […]

The Risk-Focused Future of Compliance in the Life Sciences Industry

The dialogue supporting data mining of sources such as CMS, the Company’s commercial data, EU compliance data, clinical data, Medicaid, Medicare Part B, and Part C strongly implies that a robust risk-focused future lies ahead for compliance professionals. How prepared they are to respond to such a future may be measured by their vision of […]

Will the ACA repeal impact Open Payments?

With Republican lawmakers pushing to repeal the Affordable Care Act, there is rising fear amidst researchers, media, and the public that the section of the law that created the Open Payments program, namely the Sunshine Act, will face the chopping block. For the record, the enactment of the Open Payments program has shed light on […]