FDA’s Enforcement Discretion Paves Way for Ambiguity!

Digital health has unleashed its true potential since the onset of the COVID-19 pandemic. Due to its widespread impact, it became increasingly important to come up with a solution that is scale-oriented. And in the age of digitalization, the solution came in the face of digitizing the healthcare sector.

This implication of digitalization can be seen on various levels. For instance, managing big data, remote consultation through technology, tracking details from wearables, and the like. The consequential benefits have fallen in the hands of both the providers and consumers.

In the light of digital health and related technologies, FDA is incharge of regulating and monitoring the products that flow in the market. The safety norms and manufacturing standards must be in alignment with the FDA for a product to be able to make it to the sales. However, recently FDA introduced an enforcement discretion that has an ambiguous undertone.

Before learning about this enforcement discretion that will now govern the inflow of products concerning digital health, let’s see what the role of digital health is.

How has Digital Health Management Transformed the Industry?  

Digital health is accountable for managing one of the biggest healthcare challenges, which is the COVID-19 pandemic. The need for such technology was felt due to the limitations of human providence. Not only did digital health technologies come as a boon for flattening the curve of the pandemic, but also directed the future of the medical industry.

Here is how Digital Health has proved beneficial, especially in the last year-

·         Monitoring Patient Remotely

Due to the pandemic, not many people preferred visiting the hospitals for treatment. Others couldn’t physically see a doctor due to geographical limitations. Thus popped the concept of remote consultation that is aided by technological means. Herein a specialist will be connected with a patient through technology to diagnose the issue and provide telemedicine. This has worked in favour of the patients as they have availed basic services at home.

·         Tracking Medical Parameters

One of the most common digital devices in the medical field are the wearables that track different parameters of health. This may include the steps you have walked in a day, temperature, calories burned, etc. On connecting this wearable with the physician’s data source, he will be easily able to track the progress of a patient from far away.

·         Managing/Storing Big Data

Storing and managing healthcare data is a complex task at hand. Since the amount of data is humongous, human limitations and errors do come into play. A better way of handling such big data is by entering it in the digital system. What this does is that it ceases the problem of human error. Additionally, this information can be easily passed on from one doctor to another in the time of need.

Cloud-based platforms have also ensured that the storage of such data is taken care of in a safe and secure manner.   

·         Prioritizing Emergency Cases

As medical history and current status of a patient is available at hand through data storage, doctors can easily determine which patient needs immediate attention. This betters the quality and experience of healthcare services, thus being able to save more lives.

·         Appointment Scheduling

Now that we have come far away in the digital world, nobody wants to stand in long queues to be able to see a doctor. This is also an area of concern for digital health technology. Most healthcare institutions have introduced online appointment scheduling for patients. You can save a lot of time through this. Additionally, you are sent reminders for your appointment.

·         Attending to Equipment Demand

With such a huge chain of medical requirements to meet, sometimes a slip of mind to order new equipment may lead to its shortage. However, when the equipment data is also managed online, a notification for ordering new equipment is sent well in advance. This saves the scope for any mishap.

Digital Health Management has acted in the medical industry in a broad sense. Its implications are not limited to the aforementioned areas. It is constantly expanding its horizons, thus easing the process and accessibility of availing medical services.

What is FDA’s New Enforcement Discretion?

To be able to handle the impact of COVID-19 pandemic quickly, Emergency Use Authorization (EUA) along with the Food and Drug Administration (FDA) introduced enforcement discretion. Pertaining to this, the manufacturers, importers, and distributors will be able to quickly bring concerned drugs and devices to the market. Although it is a risk-based approach to tackle the impact of the pandemic, standards and safety will not be compromised upon.

What will the Enforcement Discretion Change?

To provide wider access to products of immediate requirement, FDA has paved the way for faster market supply. For instance, products like sanitizers, face masks, etc. will follow this new guidance until the public health emergency is not over.

Adhering by the stated guidance, identified products can be distributed in the US immediately, without FDA’s prior approval. The approval earlier included regulatory requirements, quality system regulation, and registration and listing. Having said that, this novel guidance is applicable only until the emergency lasts.

Ankur Kaushal, VP of regulatory affairs and quality at Big Health, clarified the stance of FDA by  stating- “Enforcement discretion doesn’t mean no regulation. It doesn’t mean that the FDA isn’t in your life. Regulations are also very much important. 

This situation can create ambiguity for new products or new startups that have not yet complied with the FDA norms. They will have to adopt appropriate practices in order to be able to emerge clean when scrutinized under regulatory norms in the future.

Summing Up

Digital Health is a game changer for the healthcare industry. It has solved the biggest problem of data handling. Companies like Softgrid Computers have stepped up with the usage of GDPR/HIPAA compliant infrastructure to provide secure and easy data handling experience.

Due to the current emergency, FDA has removed the need for prior approval, but the standards remain the same. Assuming that you are complying by the FDA norms, a regulatory process will soon come into play as the emergency subsides. 

Posted by Ajay

Ajay is a dynamic author with over 15 years of experience in software development and management. With his vast knowledge and expertise, Ajay offers a unique perspective on industry trends, practical advice, and captivating talks. Dive into Ajay's blog to enhance your skills and stay ahead in the digital world.