Emerging technologies are fast-growing technologies with the potential to impact industries, processes, and their associated regulations. Internet of Things (IoT) is affecting changes in businesses by using data to improve sales, costs and marketing. Artificial Intelligence (AI) is working to improve current data security measures decision-making accuracy. Blockchain is implemented for the management of secure transactions throughout the internet. Robotics is taking routine processes to automation for faster and more efficient business processes. As technologies evolve to better assist in operations, their influence on regulations and compliance expands.
Emerging technologies are impacting digital compliance in the health care value chain. A technology device intended to perform a medical device function is classified as a medical device regardless of its platform. For example, if a device determines the diagnosis of a disease, conditions, cure, mitigation, treatment, or disease prevention, it is a medical device. As a result, the appropriate governing regulatory agencies determine the compliance standards for such emerging technologies.
Arbour Group’s Emerging Technology Services
At Arbour Group, we can assist with product testing for FDA filing, validation services, and additional emerging technology solutions. Technological innovations are moving faster than the speed of regulation and may include solutions such as Software as a Medical Device (SaMD), the Internet of Things (IoT), and the Internet of Medical Things (IoMT). SaMD attracts software companies accustomed to considerably 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. Arbour Group has the regulatory expertise to administer proactive emerging technology services.
Arbour Group is committed to helping you in all phases of the regulatory compliance life cycle, from the development of a robust compliance program through validation, benchmarking, investigation, remediation, and recovery in instances of misconduct or noncompliance.
For more information on Arbour Group’s Emerging Technologies Regulation and Compliance services, contact us today!