How New Regulations are Impacting the Life Science Sector

The life science sector is imposing new regulations because of the increasing cybersecurity issues.

FREMONT, CA: In addition to ensuring the safety and effectiveness of drugs, legislation in the life sciences industry seeks to ensure that innovative treatments can proceed through investigative and regulatory processes as quickly as possible. There are countless challenges, particularly as technology will continue to evolve and scientific innovations alter how drugs and devices are produced. When more devices become more complex, regulators must develop the best ways to analyze them and the fastest. Such products comprise digital pills, linked medical devices, and new molecular entities, several of which, if released to the public safely and efficiently, can enhance public health. However, continuous innovation and growth are complicated, expensive, and time-consuming, further hindered by rising safety regulations.

Medical device cybersecurity ramps up

In recent years, the scrutiny of patient data privacy has hit the tipping point, and the healthcare sector will continue to witness an advancement of cybersecurity for medical devices. More than half of providers were found to have lacked faith in the medical devices' safety, with almost one-fifth of organizations reporting malware attacks on medical devices. The FDA launched a Software Precertification Pilot Program that offers regulatory guidelines on the safety evaluation of software technologies.

The GDPR, nearer to home, has seen companies pay more attention to data security and privacy in all sectors. It meant that organizations had to protect both conventional IT systems and medical devices in the life sciences and guarantee that patient consent is obtained before gathering and processing their information. Although organizations in the life sciences may already have responded to maintain compliance with the regulations, continuous work is needed to ensure that safety is protected as technology moves ahead.

Technologies and robotics enhance regulatory activity

Robotics have made their mark in the life sciences, and it is only predicted that the use of this technology will continue to accelerate well into the future. Robotics prove their ability to perform tasks that are beyond human limits. In order to facilitate automated processes and increased regulatory supervision, next-generation technologies have been implemented, while regulators would have the power to manage more data faster, enabling them to make effective regulatory decisions. Real-time data, especially when it comes to clinical trials, can help regulators work collaboratively with the broader life sciences industry. In the near future, cloud technology, machine learning, and blockchain will have a much more significant effect on life sciences, while AI investments in the healthcare industry in 2021 is expected to hit $6.6 billion. This exponential growth of advanced technology will provide the industry with fresh regulatory challenges but represents an exciting time ahead.