Determine what you do and do not have in place and assess how risky that is to your company
Keeping Compliance Compliant
The legal and regulatory environment within the life sciences and healthcare industry is not only complex, it is also changing every day. As federal regulations expand, and as stakeholder expectations increase, organizations are becoming subjected to a greater level of scrutiny and compliance risk.
The Office of Inspector General has developed compliance program guidance with the Department of Justice and other key players in the health care industry. This guidance recommends that a compliance and ethics program contain certain “elements” and that specific standards are in place. These are known as the “seven elements” and are considered to be fundamental to an effective compliance program.
Link Compliance can ensure that your compliance program is in alignment with these seven fundamental elements. By identifying compliance gaps, we can recommend: appropriate resources; develop and deliver training; draft and implement policies; and provide organizations with the ability to establish, demonstrate and maintain a vigorous compliance structure.
Organizations are becoming increasingly subjected to a greater level of compliance risk.
Our risk assessment and gap analysis will cost-effectively evaluate the compliance risks specific to your Company. Using the OIG’s Seven Elements, Link Compliance will perform a high-level review of your compliance risk mitigation efforts with a focus on policies, practices, processes, and documents.
The results of this risk assessment and gap analysis will alert you to the possible frequency and magnitude of your risks. You will receive a prioritized, forward-looking ethics and compliance plan guiding you on how to address the risks that are unique to your industry, region and organization. Our action plans will provide you with the necessary steps to take to address and remedy gaps.
A comprehensive Compliance Program Plan is designed to monitor, detect, correct, and, as necessary, take disciplinary action, with respect to activities or practices that do not comply with the law or Company policies and expectations.
The ultimate goal of the Compliance Program Plan is to ensure that Company employees have the knowledge and resources necessary to comply with these policies, laws, rules, and regulations
Upon completion of our risk assessment and gap analysis, we will provide comprehensive recommendations on how to align your compliance program with the “seven elements”. Our proposals will constitute a detailed roadmap to achieve compliance success across your organization and Link Compliance will work with you to develop and implement all solutions.