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Key Regulatory Trends in Life Sciences
Changes are in full swing in the life sciences industry that initially emphasized more on delivering volumes of products. Their focus is shifting now to delivering improved patient outcomes and adding more value to the healthcare system. Despite the ongoing challenge of uncertainty in regulations, more and more life sciences practices are making swift progress with their compliance and risk initiatives. However, they don’t have the time and luxury to wait for regulators and lawmakers to make definitive changes. This is ample reason for the companies to keep on maintaining the efficiency and effectiveness in their compliance and risk programs to be able to meet applicable regulations, laws, and supervisory expectations.
Here are some of the key regulatory trends that life sciences companies should have a keen insight on, in order to improve from a risk and business perspective.
In order to validate a credible business need, a company is required to assess the current bona fide need for individual customer arrangements, along with the type and number of healthcare professionals (HCPs) involved, and the regularity of the activity before initiating the engagement.
Medical Device Issues
There’s an increase in the use of connected medical devices among the life sciences organizations, which brings up the issue of tackling risks related to cyber attacks and patient safety. Advisory groups such as the Association for the Advancement of Medical Instrumentation (AAMI) has released security risk management advice for connected medical devices to change how medical device manufacturers address cybersecurity concerns.
Pricing and Market Access
The Congress, the public, and regulators are focusing their attention the most on pricing and market or patient access compared to any other areas in the US life sciences industry. To ensure that patients have access to and benefit from all available products, manufacturers are creating market and patient access programs that include support for appropriately and comprehensively managing disease states.
Identification of Medicinal Products (IDMP)
Companies should be on the lookout for opportunities to harness innovation while trying to address curated information in the data from their IDMP readiness assessments. To avoid retaining duplicate data in multiple systems, companies must assess the importance of a single of truth and then integrate the existing systems. For the implementation of data governance procedures to manage the standards and definitions associated with the data, companies need to plan for a fundamental change from system owner to data owner along with the associated governance.