New pilot program could overhaul traditional health FDA practices
With interest from over 100 companies, the Food and Drug Administration is diving into its Digital Health Innovation Action plan, and has named nine companies who will become part of its new pilot plan, Pre-cert.
All companies were chosen on the basis of size, level or risk, high profile and level of quality throughout their operations within the digital industry.
The scheme will look at how technologies approach the area of quality control with regards to a growing healthcare focus, and subsequently streamline its approach towards this growing trend, enabling companies to bring products to market quicker, whilst adopting high levels of quality and safety throughout the process, leading companies to become pre-certified.
Such analysis will also enable the development of performance indicators to enable pre-certification going forward. "We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” commented FDA Commissioner, Dr Gottlieb.
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“This helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
The nine companies are as follows…
- Johnson & Johnson
- Pear Therapeutics
Such developments will see the eradication of traditional blockages and revise current regulations towards current and developing healthcare services and products, which can then be received by the patients in weeks and not months.
Corey McCann, President and Chief Executive Officer of Pear Therapeutics has stated: “We commend the FDA’s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients.
We are honoured to be at the table with these eight other companies and the FDA as we help write the new chapter on digital health and digital therapeutics.”
Long haul Covid, the brain and digital therapies
It is estimated that around 10% of people who get Covid-19 develop long haul Covid, a debilitating condition that can last many months and cause breathlessness, exhaustion and pain.
Research is underway to find out who is more likely to get it and how to treat it. Here neuroplasticity expert and owner of Harley Street Solutions in London Ashok Gupta tells us how the condition affects the brain.
What is long Covid exactly?
Long Covid is when patients who have experienced Covid-19 go on to have continuing symptoms for weeks and months afterwards. These symptoms can include breathlessness, exhaustion, brain fog, gastric issues, pain, and post-exertional malaise. It is estimated that around 10% of Covid-19 infections may result in developing long haul symptoms, and in the USA, this may be affecting over 3 million people.
How does it affect the brain?
Here at our clinic, we hypothesise that it is due to a malfunction in the unconscious brain, creating a conditioned response that keeps the body in a hyper-aroused state of defensiveness. At the core of this hypothesis is the idea that we are here because our nervous system and immune system have evolved to survive. We are survival machines!
When we encounter something such as Covid-19, the brain perceives it as life threatening, and rightly so. And in the era of the pandemic, with more stress, anxiety and social isolation, our immunity may be compromised, and therefore it may take longer for the immune system to fight off the virus and recover.
If the brain makes the decision that this is potentially life threatening and we get to the stage where we’re overcoming the virus, a legacy is left in the brain; it keeps over-responding to anything that reminds us of the virus. Even if we’ve fought off the virus, the brain will react in a precautionary way to stimuli reminiscent of the virus.
The brain may get stuck in that overprotective response, and keeps stimulating our nervous system and our immune system, just in case the virus may still be present.
What symptoms does this cause?
These signals cause a cascade of symptoms including breathlessness, extreme fatigue, brain fog, loss of taste or smell, headaches, and many others. And these are caused by our own immunes system.
In the case of long-haul Covid, symptoms in the body get detected by a hypersensitive brain which thinks we’re still in danger. The brain then chronically stimulates the immune and nervous systems, and then we have a continuation of a chronic set of symptoms.
This isn’t unique to long-haul Covid. Many patients develop chronic fatigue syndrome, sometimes known as “ME”, for example, after the flu, a stomach bug, or respiratory illness. Covid-19 may be a severe trigger of a form of chronic fatigue syndrome or ME.
How does long-haul Covid affect mental health?
Anxiety is a very common symptom in long haulers. It can be frightening to wonder about what may be happening in your body, and what the prognosis is going to be for one’s long term health. Reaching out for support for mental health is crucial for long-haulers.
How does neuroplasticity treatment work for long-haul COVID patients?
We have been working with patients for two decades with a brain retraining programme using neuroplasticity or “limbic retraining.”
We believe that through neural rewiring, the brain can be “persuaded” that we are no longer in danger and to come back to homeostasis. But to be very clear, we are not saying it is psychological in any way, but we believe there are novel ways of accessing the unconscious brain.
We recently worked successfully with a 56-year-old male with long-haul Covid, who prior to contracting Covid-19 in March of 2020 was running half-marathons and cycling, but afterwards he struggled to get off the sofa for months. Within 3 months he’s now back to 100% and running half marathons again.
At our clinic, we train the patient to be able to recognise those subtle unconscious danger signals on the periphery of consciousness. This, coupled with supportive techniques and the natural hallmarks of good health such as sleep and diet help prepare the patient to respond to perceived threats that might trigger the response.
The natural state of our brain is to default to protection. The brain prioritises survival and passing on our genes to the next generation, over any other impulse. It cares more about that than you feeling healthy and well. Protective responses are evolutionary, and are the right thing for the brain to do – it’s survival.
What digital therapies or apps are proving effective at treating long-haul Covid?
It seems that long haul patients are availing themselves of many online therapies and services, including meditation apps and wellness websites. We have an online neuroplasticity “brain retraining” video course called the “Gupta Program” which hosts 15 interactive videos and many audio exercises. This is proving very popular with long haul patients, and we are currently conducting a trial to test the effectiveness of this therapy.
What is the danger of leaving long-haul Covid untreated?
The longer it goes untreated, we hypothesise that it may become more entrenched in the brain, and become chronic in the longer term. Therefore we advise all patients to get help and advice as soon as possible.