Prognosis for Life Science Regulation

Many factors have increased pressure on life sciences companies over the past several years, including increasing regulatory requirements, nonstop technological advancements, and pricing pressure.

FREMONT, CA:  Regulatory requirements, technological advancements, and significant pricing pressure have all increased pressure on life science companies over the past few years. And the unusual events of the previous year gave even more justification for modernizing compliance and elevating the value and partnerships within organizations and with external stakeholders.

Companies in the life sciences must confront the industry's new problems head-on if they wish to maintain their position as market leaders and maintain their position as market leaders. It is time for compliance to focus on the future rather than the past.

This year's regulatory forecast emphasizes the need for life sciences enterprises to view their compliance activities as an integrated element of their overall business strategy.

USING TECHNOLOGY TO IMPROVE COMPLIANCE MONITORING AS PART OF A DIGITAL TRANSFORMATION

Compliance teams are under constant pressure to accomplish more with fewer resources, necessitating a fundamental transformation involving technology accelerators. Once these new technologies are operational, they can improve an organization's efficiency, effectiveness, and ability to safeguard its business and deliver measurable value.

These transformational technologies include robotic process automation, processing, and production of natural language, predictive analytics, artificial intelligence, and machine learning. 

VIRTUAL INTERACTIONS BETWEEN HEALTHCARE PROFESSIONALS 

Regulators, lawmakers, and the media scrutinize relationships between businesses and healthcare practitioners with great attention. As more of these interactions and fee-for-service relationships become virtual—a trend accelerated by the COVID-19 pandemic—healthcare organizations will likely need to make additional modifications to comply with life sciences standards.

Companies in the life sciences should consider speaker programs, fair market value, meals, and potential violations of laws and regulations. 

MANAGEMENT OF THIRD-PARTY RISK: PATIENT SUPPORT PROGRAM

COVID-19 has pushed the limits of existing patient support programs (PSP) and increased demand and need, which has resulted in changes in how patients become aware of and interact with these programs, in addition to changes in reimbursement, access, and adherence services.

Many life sciences manufacturers have sophisticated third-party risk management processes across their enterprises; however, these programs are rarely implemented for PSP providers. Numerous companies in the life sciences outsource their PSPs to third-party suppliers that offer a variety of services. However, when a third party is involved, other hazards emerge. Learn how using advanced analytics for third-party risk audits can help decrease risk exposure, provide compliance insights, and produce business value by reading our entire report.