New opportunities for regulatory compliance in life sciences and health care

Compliance and regulatory professionals see challenges mounting

In the United States and globally, compliance and regulatory professionals see challenges mounting in the years ahead. While some life sciences and health care organizations have elevated their compliance and regulatory functions, many have not yet organized to meet new demands.

• Regulators demand more, as their surveillance tightens and their tools for monitoring compliance improve.
• Society demands more, expecting life sciences and health care organizations to enable health equity, protect information privacy and security, achieve sustainability, and reflect diversity and inclusion, all on behalf of a growing range of stakeholders.
• And business needs demand more, with intense competition, pressure on resources, increased use of disruptive technology, and ever-greater needs for insight and analysis.

Overcoming numerous hurdles

Compliance should shift its focus from hindsight to foresight and, even more important, insight—deploying its data and tools to identify process improvements, control efficiencies, and new opportunities. To evolve compliance programs to effectively meet today’s demands and prepare for tomorrow, life sciences and health care organizations should strive to overcome numerous hurdles, including:

• Disparate and inconsistent policies, processes, and systems that increase compliance burden without improving compliance.
• Resource constraints resulting from organizational contraction, time and talent consumed by routine regulatory tasks, rule enforcement, and lack of digital tools and capabilities to meet new challenges.
• The brand of compliance professionals as watchdogs, enforcers, or cleanup crews, rather than as active partners in ensuring that the business grows while maintaining the highest standards of ethics, integrity, and trust.
• Lack of consistent accountability and ownership for compliant outcomes throughout the business, which may view risk management as an afterthought and compliance as a safety net, rather than a key component of business decision-making.
   

What does a modernized compliance program look like?

To prepare for what’s to come, compliance programs should be:

• Encompassing: Respond to regulator and stakeholder demands by following through with commitments.
• Embedded: Establish compliance routines by making it part of the organization’s culture.
• Agile: Create compliance systems that can adapt to dynamic regulatory and public expectations.
• Tech savvy: Optimize workflows with digital interfaces to help accelerate compliance, even with limited resources.
• Strategic: Incorporate forward-thinking practices to help reinforce the proactive elements of risk management.

How can compliance programs evolve?

Compliance organizations can be classified on a spectrum from basic—fulfilling traditional rule-based functions—to value-creating with compliance as an integral contributor to business innovation and growth. To move up the maturity curve, transition requires changes in technology, approach, staffing, and roles. It also requires a robust process of careful change management.

Ready to make compliance less complicated? Reach out to our team and let’s discuss ways to create value for your organization with modernized compliance.