Life sciences compliance, pricing, and contracting insights and updates

The rapid evolution of AI technology in the life sciences sector is met with an equally dynamic global AI regulatory landscape. Business leaders are faced with the challenge of navigating diverse and complex regulations that vary significantly across jurisdictions. How can they balance the duality of fostering innovation while mitigating risks?

Within the life sciences industry, companies are under scrutiny by regulators to provide a level of transparency and disclosure where spending on services is reported in accordance with several state laws and federal provisions.

In 2025, regulatory and compliance functions within life sciences organizations are poised for significant technical transformation. As organizations embrace these advancements, they will need to strengthen governance and monitoring frameworks to address ethical concerns, privacy issues, and potential biases associated with emerging technologies.

The medtech industry needs to navigate the regulatory landscape carefully while scaling AI and GenAI for transformation.

Continuous monitoring is vital for achieving robust compliance and effective risk management within the life sciences sector.

Life sciences and health care organizations need to establish and maintain trust to operate—and compliance is essential to that trust. As the environment for these industries grows increasingly pressured in 2024 and beyond, it’s no longer enough to follow the rules, check the boxes, and investigate any failings.

Tech-enablement, when done correctly, can help improve the effectiveness of a risk management program while helping to manage budgets and handle change management and user adoption

Compensation arrangements between life sciences companies and DOLs require a new calculus that considers online engagement metrics and more.

A heightened regulatory focus coupled with increased virtual assessments will likely drive organizations to take a more structured, tech-enabled approach to managing high-risk third parties

While Generative AI (GenAI) has much promise, the global AI regulatory environment could pose challenges for the life sciences industry. Clarity in the regulatory environment can help accelerate the AI journey and adoption across regions. Explore the regulatory environment of AI in six geographical jurisdictions.

In this article, we’ll explore health care professional (HCP) contracting processes and their associated potential risks to be considered. We will also share considerations to streamline the process that allows life sciences companies to potentially improve compliance, reduce their operational burden, and maximize the value they get from the HCP relationships.

Access to artificial intelligence (AI)-powered tools and flexible automation workflows has revolutionized how monitoring activities are performed—teams are now finding more relevant information in significantly less time. So, what’s next?

On March 24, 2022, the Advanced Medical and Technology Association (“AdvaMed”) announced that it updated its Code of Ethics on Interactions with Health Care Professionals (HCPs) in the United States. Learn more about the compliance guidance updates for MedTech companies and the six new FAQs AdvaMed added to clarify critical concepts.

Many US states have enacted new state drug price transparency legislation or amended current legislation to address prescription drug costs and spending, which poses operational challenges for manufacturers to maintain compliance with these new requirements. Explore this report to understand how this legislation may impact your unique business requirements.

On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it updated its Code on Interactions with Health Care Professionals (“PhRMA Code”). The changes included in this update primarily focus on company-sponsored speaker programs. What are the new insertions into the PhRMA Code and some of the other critical changes?

The Special Fraud Alert: Speaker Programs was released to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of renumeration relating to speaker programs by pharmaceutical and medical device companies.” What does it mean for life sciences organizations and what actions should you consider taking?

Pharmacy Benefit Manager (PBM) final rule delayed again: What now?
While the PBM final rule is delayed, it is important for pharmaceutical manufacturers to continue to evaluate their current service arrangements (including PBM agreements) from a bona fide service fee (BFSF) and fair market value (FMV) perspective.