Digital compliance is ensuring that an organization is complying with minimum security and privacy-related requirements. Whether you are a pharmaceutical, biotech, clinical laboratory, or medical device organization, you must prepare for and manage regulatory review and enforcement actions. Complying with digital security needs is also critical for organizations operating within the health care value chain. 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. Failing to comply with changing regulations can have serious consequences, including fines, criminal prosecution, and debarments.
Advances in Digital Regulatory Compliance Services for the Life Sciences Industry
With some of the more recent trends across many industries, technological innovations are moving faster than the speed of regulation. In many cases, regulatory compliance solutions fall 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).
The advent of Software as a Medical Device (SaMD) provides another clear example of new regulatory compliance services and post-approval concerns. SaMD attracts software companies 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 monitoring that are considered standard digital regulatory compliance services by more traditional manufacturers, and many have already become caught up in regulatory compliance and reputational risk. However, even traditional device and pharmaceutical manufacturers may face challenges and issues complying with the unique risks associated with SaMD products.
Thanks to advances in artificial intelligence (AI), life sciences manufacturers are exploring new ways to automate critical elements of the risk identification, auditing, and monitoring processes, 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 regulatory compliance risks accordingly, and manage investigations more effectively.
How AI is Taking Predictive Analytics to the Next Level
Combining AI analysis with predictive analytics can enable modeling techniques to assess digital 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 regulatory compliance specialists and others. Machine learning combs 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, digital compliance and regulatory services can move beyond sampling and spot checks to analyze the full universe of activities they monitor. As knowledge bases become more robust with digital compliance rules and learning algorithms advance, we expect AI to become more integrated into the life sciences digital compliance monitoring regimen.
If you have digital compliance and regulatory compliance service 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 ensuring digital regulatory compliance solutions, as well as reassessing and retooling your compliance governance, compliance culture, business and risk operations. Align your digital compliance programs to the specific regulatory requirements of your industry, anticipating regulatory changes, and achieve industry-leading results.
Digital Compliance Services at Arbour Group
At Arbour Group, we specialize in regulatory compliance consulting services. We can help you assess business practices and monitor programs to avoid problems proactively. When necessary, we investigate and partner to help you manage the potential consequences of alleged digital compliance failures. Arbour Group can help you in all phases of the regulatory compliance life cycle, from the development of a robust compliance consultation program through benchmarking, investigation, remediation, and recovery in instances of misconduct or noncompliance.
Moreover, we focus on the people, processes, and technology that help meet and exceed your digital compliance needs. Arbour Group educates, transforms, and re-engineers your crucial 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, with a clear set of technical systems, tools, and processes put in place to protect and defend the information and technology assets of an enterprise. Arbour Group works with you to address both digital compliance and cyber security.
Contact Arbour Group to discuss how your organization manages digital compliance security and privacy-related requirements.