New opportunities for regulatory compliance in life sciences and health care has been saved
Perspectives
New opportunities for regulatory compliance in life sciences and health care
How organizations can meet growing demands—and go beyond
Life sciences and health care (LSHC) 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. Compliance modernization has become crucial.
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.
New opportunities for compliance in life sciences and health care
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.
The promise—and perils—of Generative AI
Generative AI (GenAI) is reshaping the health care landscape; its transformative power extends across domains. That power can be used to not only enhance productivity and reduce costs but also streamline compliance processes and help improve outcomes. However, with this strong capability comes significant ethical questions, growing regulatory requirements, and a need for strong governance and monitoring. For compliance professionals, GenAI is both an appealing opportunity and a source for concern.
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.
Explore use cases of organizations putting value-creating compliance into action
A global pharmaceutical firm wanted to enhance training, monitoring, and auditing of its associates’ meetings with health care professionals. Deloitte provides ongoing service to train associates and to conduct compliance checks before, during, and after events and meetings. Consistent, streamlined monitoring helps the firm increase efficiency and reduce risk, and continuous data analysis provides additional insights into process performance and compliance metrics.
A global pharmaceutical company was confronted with multiple complex and disparate systems for compliance, leading to higher costs, poor communication, and ineffective reporting capabilities. Deloitte evaluated multiple platform options against a diagnosis of the current state and an evaluation of future needs. Implementation reduced 21 unique systems to nine and has provided consistent end-to-end workflow management, enhanced information-sharing and reporting capabilities and scalable systems, and improved user experience.
A health care system’s program for revenue cycle compliance was inefficient, narrowly focused on provider billing, and often reactive with minimal education and process improvement support. Deloitte implemented a program that leverages data to continuously identify risk areas, trends, and patterns and enable a continuous risk-based auditing, monitoring, and education program, supported by a global delivery center of industry specialists. By deploying standardized audit approaches, pre- and post-audit communications, data-driven reporting, and post-audit education for providers and coders, billing compliance risks are reduced while the stakeholder experience with compliance is greatly strengthened. In addition to auditing and monitoring, Deloitte provides ongoing assistance for helpline issues, investigations, new provider onboarding, and education on regulatory changes.
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.
Heather Hagan |
Clarissa Crain
|
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