Digital compliance is critical for both commercial and governmental organizations. For example, whether you are in the healthcare and life sciences industry or a one that requires meeting privacy or regulatory you must prepare for and manage review and enforcement actions. Failing to comply with changing regulation can have serious consequences, including fines, criminal prosecution, and debarments. In addition, digital compliance means ensuring an organization is complying to the minimum of the security and privacy related requirements. Furthermore, with the movement to the Cloud and the evolution and convergence of technology, organizations in the health care value chain and cloud service providers must work together to meet regulatory obligations from organizations like the Food and Drug Administration depending on the solution or technology platform being used.
At KPG Global Enterprises, we can help you assess business practices and monitor programs to avoid problems proactively and, when necessary, we investigate and partner to help you manage the potential consequences of alleged compliance failures. In addition, we can help you in all phases of the regulatory compliance life cycle, from the development of a robust compliance program through benchmarking, investigation, remediation, and recovery in instances of misconduct or noncompliance.
To ensure effective solutions, we utilize solutions such as:
- Emerging Technologies (i.e., SaMD)
- Cloud Compliance
- Cyber Security
- Data Privacy & GDPR
- Artificial Intelligence
- ERP Security/GRC
- Data Compliance
Moreover, we focus on the people, processes, and technology that will help you meet and exceed with digital compliance. We will help educate your people and transform and re-engineer your key business processes. Furthermore, we utilize technology enablers like Cyber Security, Artificial Intelligence, Robotic Process Automation, Data Science and Analytics, and Emerging technologies to ensure effective solutions. We keep in mind that compliance does not necessarily equal security, which is a clear set of technical systems and tools and processes which are put in place to protect and defend the information and technology assets of an enterprise. However, we work with you to ensure both digital compliance and cyber security are addressed.
Some of the more recent trends across many industries, technological innovations are moving faster than the speed of regulation. In many cases, regulation falls behind when new products challenge the established taxonomies of products that the regulator has traditionally overseen. In the medical device industry, this change has been especially notable in software-enabled products—devices that generate, analyze, and transmit health data via the Internet of Medical Things (IoMT).
Moreover, the advent of Software as a Medical Device (SaMD) provides another clear example of new regulatory and post-approval concerns. SaMD attracts software companies that are often accustomed to far faster product cycles and minimal government oversight. Without experience working with regulators, these companies are unlikely to have developed the controls and oversight that are considered standard compliance guardrails by more traditional manufacturers, and many have already become caught up in regulatory and reputational risk. However, even traditional device and pharmaceutical manufacturers may face challenges and issues complying with the unique risks associated with SaMD products.
In addition, thanks to advances in artificial intelligence (AI), life sciences manufacturers are exploring new ways to automate key elements of the risk identification, auditing, and monitoring process—and are capitalizing on opportunities to use data from monitoring in their strategic decision-making. These AI-driven improvements can help companies proactively identify anomalies, prioritize life sciences compliance risks accordingly, and manage investigations more effectively.
Combining AI analysis with predictive analytics can enable modeling techniques to assess compliance risk on a prospective basis, helping users make timely and informed decisions to address identified anomalies. With insights from AI applications, monitoring risk data can become a far more useful tool for compliance officers and others. Machine learning can be used to comb through large data sets, not only to identify potential risk areas but also to optimize the use of resources and uncover performance trends in provider engagements that are difficult to identify through manual processes.
With these advances, compliance programs can move beyond sampling and spot checks to analyze the full universe of activities they monitor. As knowledge bases become more robust with compliance rules—and learning algorithms become more advanced—we expect AI to become more integrated into the life sciences compliance monitoring regimen.
If you have digital compliance needs, we ask that you contact us so that we can help your organization move forward in meeting and exceeding your objectives. We can assist your organization in fundamentally reassessing and retooling your compliance governance, compliance culture, and business and risk operations. This includes aligning your compliance programs to the specific requirements of your industry, anticipating regulatory changes, and helping achieve industry leading results.
