Life Science Topics - Sunshine Act

If your organization is like most these days, resources are tight and teams are lean. Efficiency becomes a key ingredient to an effective compliance program. Running lean doesn’t mean corners must be cut or best practices need to be sacrificed. Below are five ways to keep your healthcare professional (HCP) engagement process in great shape. [...]

One of the key areas of focus for compliance teams is pre-empting and managing risk across the organization before it becomes a compliance issue. Given that there could be many different sources of risk, especially in large global organizations, compliance teams need access to tools that can help them monitor and manage risk in a [...]

As engagements between life sciences companies and healthcare professionals (HCPs) become more frequent and complex, the financial ties associated with those engagements continue to create significant compliance risk for many life sciences organizations. While there are many benefits to increased HCP engagements, such as helping to design clinical trials, conducting continuing medical education, developing clinical [...]

Building a transparency reporting program is easy. Building an effective transparency reporting program, however, is much more challenging. Partnering with over a hundred medical device and pharmaceutical companies, I have had a first-hand opportunity to build from scratch, enhance and overhaul numerous transparency programs focused on U.S. and global reporting requirements. Through my experience, I [...]

The Centers for Medicare & Medicaid Services recently published their 2019 Open Payments data. In the 2019 report, which includes transactions that took place between Jan. 1 and Dec. 31, 2019, applicable manufacturers reported $10.03 billion in publishable payments, ownership, and investment interests to healthcare professionals (HCPs) and healthcare organizations (HCOs), which is approximately 680 [...]

On June 17, 2020, an important decree related to “anti-benefits” was published in France, including the ministerial orders implementing this decree. The new rules contain changes in the regulatory framework for interactions between the industry and healthcare professionals (HCPs). A summary of the decree can be found below and a link to the full decree [...]

The Maine Board of Pharmacy finalized its gift ban rule last month, providing guidance for manufacturers and wholesalers over a year after initial regulations were proposed. The final rule, effective June 6, provides guidance on minimal value in relation to modest meals and refreshments, reasonable honoraria and research. The Board clarified that the gift ban [...]

As mentioned in a blog published last year, EPFIA consolidated their three EFPIA Codes (PO – HCP – Disclosure) into one simplified Code. EFPIA stated their reasons to consolidate the Codes were “the simplification of concepts, the removal of repetitive provisions and the clarification of the content”. Member Associations were asked to transpose the revised Code provisions [...]

1. Implementation Time Investment A migration to a SaaS solution may seem intimidating and you might have concerns about the bandwidth of your IT department for such a project. Typically, the actual implementation and rollout of a SaaS solution is a relatively quick and easy process. In fact, most pharmaceutical and medical device companies will [...]

On June 1, 2020, the Department of Justice (DOJ) updated its guidance document on the “Evaluation of Corporate Compliance Programs.” As outlined below, the DOJ identifies the adequacy of resources and the access to data and analytics as key components to establishing an effective compliance program. The original version of the guidance document was published [...]