Scientists say they have devised a way to screen for prostate cancer using a drop of urine, a sensor, and AI algorithms. And the test takes just twenty minutes, and is 99 per cent accurate, according to results from a small-scale test.
The risk of developing prostate cancer increases for men as they get older, and the over 50s are supposed to be routinely screened for the disease. If the examination – performed either with a blood test or something… more hands on – suggests there’s a problem, the patient may undergo a biopsy, where a small amount of tissue is extracted from the prostate to confirm whether or not there are cancerous cells present. But these screening tests tend to generate a lot of false positives, leading to unnecessary biopsies.
A team of researchers led by the Korea Institute of Science and Technology (KIST) believe that prostate cancer can be screened non-invasively and quickly using just a urine sample. If high levels of PCA3 are detected, there’s a high chance of prostate cancer.
Urine tests, however, can also be inaccurate at predicting whether someone really needs a biopsy or not. Instead of looking for just PCA3, the team uses a biosensor made up of a dual-gate field effect transistor to sense the presence of biomarkers in the urine. These biomarkers cause a shift in the transistor’s reference voltage.
By measuring this change after a tiny drop of urine is placed on the biosensor’s surface, scientists can determine the concentration of the biomarkers in the fluid. Trained algorithms can take these concentration readings, and use them to predict whether or not someone has the disease.
“Basically, a biomarker is a certain substance in our body where its concentration is affected by a specific disease state,” Kwanhyi Lee – co-author of a paper describing the technology, published in ACS Nano, and a principal research scientist at KIST – explained to The Register on Tuesday.
“In our study, we chose four different biomarkers related to prostate cancer. Simply speaking, we see either an increase or decrease of biomarker concentration from cancer patients compared to healthy individuals.
Study: AI designed to detect diabetic eye disease blinks in the real world, makes more work for doctors
“In a single biomarker based diagnosis, we can simply set the threshold to diagnose the disease. However, when there are more biomarkers, four in our case, understanding the relation between biomarker data and disease state is not easy. Considering the potential of multiple biomarker based diagnosis, it is necessary to analyze multiple biomarker data. Here, we utilized AI algorithms to learn the pattern of biomarker data so that the AI algorithm predicts the cancer.”
The algorithms were trained to look for specific patterns in the biomarker data that are common in patients with prostate cancer. If they detect the same patterns in a fresh urine sample, there’s a high chance of the disease. The team collected 76 urine samples from a mixture of healthy patients and men with prostate cancer, and used 70 per cent of them to train the algorithms and 30 per cent for testing.
Initial results show that the algorithms were able to correctly predict with at least 99 per cent accuracy whether someone had prostate cancer or not. It should be noted, however, that only 23 people were tested in the experiment so the results of this limited experiment should be taken with a pinch of salt.
After a further development of the technology, I believe that replacing the current blood test will be possible
Lee said that although the false positive and negative rates of the algorithms were low at 0.024 and 0.037 respectively, the team needed to verify their results with many more patients.
“After a further development of the technology, I believe that replacing the current blood test will be possible,” he said. “To make this happen, there are a few challenges we need to overcome. First, a validation of our approach with a much larger data set should be checked. Second, miniaturization of the sensor is needed.
“And then we need to closely work with healthcare experts on fields to monitor the performance of our sensing platform to determine replacing the current blood-based test. Personally, I think that making the sensing platform more affordable without compromising the performance is the key.”
At the moment, Lee believes the test is not yet good enough to completely eradicate the need for further biopsy tests. He hopes that one day in the future the team will develop a biosensor capable of detecting multiple biomarkers for different cancers that can be analysed with AI algorithms to diagnose patients. ®
iMe Messenger and Crypto Wallet Review: Designed for Secure Chats and Low-Fee DeFi
The iMe Messenger and Crypto Wallet, developed by iMe Lab, is a five-star multi-functional client powered by Telegram API. Telegram is a privacy-focused messenger and one of the world’s largest applications.
Leveraging Telegram APIs
This means the platform incorporates some of the critical features of Telegram and aspects of decentralized finance (DeFi), essentially becoming a Telegram client with crypto wallet support.
Aiming to revolutionize messaging, the iMe Messenger also has integrated tools and leverages artificial intelligence and blockchain.
Combining all these features and integration makes the iMe Messenger and Crypto Wallet multi-functional, fast, powerful, and private.
All user data are secured in a multi-cloud, ensuring privacy is protected–an impeachable human right.
iMe Messenger Features
The iMe Messenger is designed to work for chats.
Accordingly, the client has specific topics and chats folders complete with advanced settings for tabs and folders.
This, in turn, introduces unparalleled levels of flexibility, allowing the end-user to sort and archive chats. At the same time, users can listen to music from the app’s music player while chatting from the same device.
For easy client onboarding, the iMe Messenger has specifically designed the front end and the user interface to be easy to use, regardless of a user’s tech-savviness.
For instance, the messenger boasts a side menu setting, and users can filter contacts. There is also a multi-panel in chats.
At the same time, they can disable the bottom bar in their respective channels. All iMe Messenger settings can also be backed up in the cloud. It is convenient, especially for users who may want to change devices but keen not to lose previous settings.
The messenger goes a notch higher for differentiation, especially in the array of tools it avails to users. Once installed and chatting, a user can multi-forward chats. Concurrently, they can also multi-reply in groups.
Users chatting in multilingual groups/channels can also auto-translate incoming and outgoing messages. Additionally, users can convert voice messages into text, extract text from images, and make descriptions of images.
Those in the move or busy not to reply can activate neurobots-assistants that can step in and offer quick replies in phrases and GIFs.
The iMe Messenger Crypto Wallet is also multi-currency and forms a critical part of the iMe Smart Platform. Their merger of exciting features of Telegram and support of cryptocurrency—and by extension DeFi, makes iMe one of the most advanced messenger applications.
iMe Messenger has been downloaded over 634k times. The application has over 93k active users, of whom most use Android devices.
Cryptocurrency Support and DeFi
The application is also a cryptocurrency wallet supporting some of the leading coins and DeFi tokens. Top of the list is ETH and USDT. Ether (ETH) is the native currency of the Ethereum network that’s now the home of DeFi.
According to trackers, there are over $40 billion of digital assets managed by Ethereum-based DeFi protocols. The USDT token is an enabler, allowing users to interact with the various DeFi dApps.
Already, iMe Messenger has integrated Uniswap. The DeFi protocol is the largest decentralized exchange globally, allowing the trustless exchange of tokens through incentivized pools where liquidity providers (LPs) earn rewards.
Beyond DeFi tokens, iMe Messenger enables secure storage of LIME and OLCF. Through the platform, users can safely store, trade, and transfer these coins within chats. The platform also has its native currency, AiCoin. It enables in-app monetization and acts as a means of calculation.
For faster and seamless entry into crypto, iMe Messenger has partnered with Simplex. Users can purchase supported cryptocurrencies using their credit cards. This helps in driving adoption and improving awareness of cryptocurrencies.
Simplex is a regulated financial institution that allows users to deploy a range of channels as payment options.
To further enhance the user experience, especially those actively involved in DeFi, the iMe Messenger has integrated with the Binance Smart Chain (BSC).
The smart contracting platform fronted by Binance is compatible with the Ethereum Virtual Machine (EVM), and transacting via the network is relatively cheap and faster since the platform is scalable.
Telegram — https://t.me/ime_en
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Deep Science: AI adventures in arts and letters
There’s more AI news out there than anyone can possibly keep up with. But you can stay tolerably up to date on the most interesting developments with this column, which collects AI and machine learning advancements from around the world and explains why they might be important to tech, startups or civilization.
To begin on a lighthearted note: The ways researchers find to apply machine learning to the arts are always interesting — though not always practical. A team from the University of Washington wanted to see if a computer vision system could learn to tell what is being played on a piano just from an overhead view of the keys and the player’s hands.
Audeo, the system trained by Eli Shlizerman, Kun Su and Xiulong Liu, watches video of piano playing and first extracts a piano-roll-like simple sequence of key presses. Then it adds expression in the form of length and strength of the presses, and lastly polishes it up for input into a MIDI synthesizer for output. The results are a little loose but definitely recognizable.
“To create music that sounds like it could be played in a musical performance was previously believed to be impossible,” said Shlizerman. “An algorithm needs to figure out the cues, or ‘features,’ in the video frames that are related to generating music, and it needs to ‘imagine’ the sound that’s happening in between the video frames. It requires a system that is both precise and imaginative. The fact that we achieved music that sounded pretty good was a surprise.”
Another from the field of arts and letters is this extremely fascinating research into computational unfolding of ancient letters too delicate to handle. The MIT team was looking at “locked” letters from the 17th century that are so intricately folded and sealed that to remove the letter and flatten it might permanently damage them. Their approach was to X-ray the letters and set a new, advanced algorithm to work deciphering the resulting imagery.
“The algorithm ends up doing an impressive job at separating the layers of paper, despite their extreme thinness and tiny gaps between them, sometimes less than the resolution of the scan,” MIT’s Erik Demaine said. “We weren’t sure it would be possible.” The work may be applicable to many kinds of documents that are difficult for simple X-ray techniques to unravel. It’s a bit of a stretch to categorize this as “machine learning,” but it was too interesting not to include. Read the full paper at Nature Communications.
You arrive at a charge point for your electric car and find it to be out of service. You might even leave a bad review online. In fact, thousands of such reviews exist and constitute a potentially very useful map for municipalities looking to expand electric vehicle infrastructure.
Georgia Tech’s Omar Asensio trained a natural language processing model on such reviews and it soon became an expert at parsing them by the thousands and squeezing out insights like where outages were common, comparative cost and other factors.
Will Artificial Intelligence Replace Portfolio Managers in The Financial Industry?
I’m an Entrepreneur, Artificial Intelligence expert and Software Engineer with over 15 years of experience.
Artificial Intelligence (AI) chess gamers and poker players have already proven they could beat human masters. What’s to stop AI from doing the same with financial markets? What happens when AI becomes a portfolio player?
To some extent, it already has, even though investment success relies strongly on human interactions. In fact, very few industries depend on employees’ decisions as much as the financial markets. With AI, are these human decisions being overwritten by machine learning?
The reality is that “algorithm trading” has already impinged the market, exacerbating the exclusive Down Jones plummet of 700 points in 20 minutes back in February 2018. Traders and analysts agreed that the growing speed of algorithm trading models and automated sell orders impacted the collapse that day.
There are many positive roles that AI can play in the financial industry. AI algorithms can reduce risk, detect and manage fraud, improve operational efficiencies, and deliver improved customer services.
For example, there are systems currently in place within banks and other financial institutions that flag irregular behavior on accounts. Machine learning takes this function to a higher level by providing information that is much more sophisticated and precise.
The Financial Times reported a case of identity theft that was detected when the criminal used the scroll bar on a user’s site. The actual user consistently used a trackpad when banking online, and based on this inconsistency, the bank’s AI picked up the discrepancy. Technology efficiencies are already in place with many large finance corporations. AI again goes beyond this as algorithms provide highly-functioning robotics for operational processes and customer service.
The greatest intrusion and the biggest impact on the finance sector — whether it’s perceived as good or bad — is that major banks and hedge funds are using information gleaned from machine learning algorithms to advise clients on portfolio investments.
According to Deloitte, the pre-AI analysis relied on financial statements, earnings reports, press releases, investor presentations, blogs, and news articles. The process was painstakingly tedious. Today, AI analytics are now able to process these sources of information. They also process digital and non-traditional massive amounts of data such as web and social media information. This data can be calculated using natural language processing capabilities to give investors instantaneous trading tips. But, here’s the caveat:
Past performance is not necessarily an indicator of future performance.
It’s the footnote on any investment report or statement, and it is a critical factor to keep in mind when selecting investment advisors or portfolio managers based on their AI capabilities. While all the newly available data can improve holding decisions, there are intangible market factors and an advisor’s intuition that won’t always be captured by AI.
Keeping that in mind, prudent investors should do their own research and ask their advisor how AI is playing a part in their company’s processes. It’s safe to say that firms that are not actively gathering big data and employing AI processes with sophisticated algorithms will not remain competitive in the future.
As financial investors continue to have angst over AI and the markets, the logical viewpoint that Mike Chen, an equity portfolio manager at PanAngora, shared with CNN in an interview earlier this year is a great stance, “It’s not man versus machine. It’s man plus machine.”
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UK’s MHRA says it has ‘concerns’ about Babylon Health — and flags legal gap around triage chatbots
The U.K.’s medical device regulator has admitted it has concerns about VC-backed AI chatbot maker Babylon Health. It made the admission in a letter sent to a clinician who’s been raising the alarm about Babylon’s approach toward patient safety and corporate governance since 2017.
The HSJ reported on the MHRA’s letter to Dr. David Watkins yesterday. TechCrunch has reviewed the letter (see below), which is dated December 4, 2020. We’ve also seen additional context about what was discussed in a meeting referenced in the letter, as well as reviewing other correspondence between Watkins and the regulator in which he details a number of wide-ranging concerns.
In an interview he emphasized that the concerns the regulator shares are “far broader” than the (important but) single issue of chatbot safety.
“The issues relate to the corporate governance of the company — how they approach safety concerns. How they approach people who raise safety concerns,” Watkins told TechCrunch. “That’s the concern. And some of the ethics around the mispromoting of medical devices.
“The overall story is they did promote something that was dangerously flawed. They made misleading claims with regards to how [the chatbot] should be used — its intended use — with [Babylon CEO] Ali Parsa promoting it as a ‘diagnostic’ system — which was never the case. The chatbot was never approved for ‘diagnosis.’”
“In my opinion, in 2018 the MHRA should have taken a much firmer stance with Babylon and made it clear to the public that the claims that were being made were false — and that the technology was not approved for use in the way that Babylon were promoting it,” he went on. “That should have happened and it didn’t happen because the regulations at that time were not fit for purpose.”
“In reality there is no regulatory ‘approval’ process for these technologies and the legislation doesn’t require a company to act ethically,” Watkins also told us. “We’re reliant on the health tech sector behaving responsibly.”
The consultant oncologist began raising red flags about Babylon with U.K. healthcare regulators (CQC/MHRA) as early as February 2017 — initially over the “apparent absence of any robust clinical testing or validation,” as he puts it in correspondence to regulators. However with Babylon opting to deny problems and go on the attack against critics his concerns mounted.
An admission by the medical devices regulator that all Watkins’ concerns are “valid” and are “ones that we share” blows Babylon’s deflective PR tactics out of the water.
“Babylon cannot say that they have always adhered to the regulatory requirements — at times they have not adhered to the regulatory requirements. At different points throughout the development of their system,” Watkins also told us, adding: “Babylon never took the safety concerns as seriously as they should have. Hence this issue has dragged on over a more than three-year period.”
During this time the company has been steaming ahead inking wide-ranging “digitization” deals with healthcare providers around the world — including a 10-year deal agreed with the U.K. city of Wolverhampton last year to provide an integrated app that’s intended to have a reach of 300,000 people.
It also has a 10-year agreement with the government of Rwanda to support digitization of its health system, including via digitally enabled triage. Other markets it’s rolled into include the U.S., Canada and Saudi Arabia.
Babylon says it now covers more than 20 million patients and has done 8 million consultations and “AI interactions” globally. But is it operating to the high standards people would expect of a medical device company?
Safety, ethical and governance concerns
In a written summary, dated October 22, of a video call which took place between Watkins and the U.K. medical devices regulator on September 24 last year, he summarizes what was discussed in the following way: “I talked through and expanded on each of the points outlined in the document, specifically; the misleading claims, the dangerous flaws and Babylon’s attempts to deny/suppress the safety issues.”
In his account of this meeting, Watkins goes on to report: “There appeared to be general agreement that Babylon’s corporate behavior and governance fell below the standards expected of a medical device/healthcare provider.”
“I was informed that Babylon Health would not be shown leniency (given their relationship with [U.K. health secretary] Matt Hancock),” he also notes in the summary — a reference to Hancock being a publicly enthusiastic user of Babylon’s “GP at hand” app (for which he was accused in 2018 of breaking the ministerial code).
In a separate document, which Watkins compiled and sent to the regulator last year, he details 14 areas of concern — covering issues including the safety of the Babylon chatbot’s triage; “misleading and conflicting” T&Cs — which he says contradict promotional claims it has made to hype the product; as well as what he describes as a “multitude of ethical and governance concerns” — including its aggressive response to anyone who raises concerns about the safety and efficacy of its technology.
This has included a public attack campaign against Watkins himself, which we reported on last year; as well as what he lists in the document as “legal threats to avoid scrutiny and adverse media coverage.”
Here he notes that Babylon’s response to safety concerns he had raised back in 2018 — which had been reported on by the HSJ — was also to go on the attack, with the company claiming then that “vested interest” were spreading “false allegations” in an attempt to “see us fail.”
“The allegations were not false and it is clear that Babylon chose to mislead the HSJ readership, opting to place patients at risk of harm, in order to protect their own reputation,” writes Watkins in associated commentary to the regulator.
He goes on to point out that, in May 2018, the MHRA had itself independently notified Babylon Health of two incidents related to the safety of its chatbot (one involving missed symptoms of a heart attack, another missed symptoms of DVT) — yet the company still went on to publicly rubbish the HSJ’s report the following month (which was entitled: “Safety regulators investigating concerns about Babylon’s ‘chatbot’”).
Wider governance and operational concerns Watkins raises in the document include Babylon’s use of staff NDAs — which he argues leads to a culture inside the company where staff feel unable to speak out about any safety concerns they may have; and what he calls “inadequate medical device vigilance” (whereby he says the Babylon bot doesn’t routinely request feedback on the patient outcome post triage, arguing that: “The absence of any robust feedback system significant impairs the ability to identify adverse outcomes”).
Re: unvarnished staff opinions, it’s interesting to note that Babylon’s Glassdoor rating at the time of writing is just 2.9 stars — with only a minority of reviewers saying they would recommend the company to a friend and where Parsa’s approval rating as CEO is also only 45% on aggregate. (“The technology is outdated and flawed,” writes one Glassdoor reviewer who is listed as a current Babylon Health employee working as a clinical ops associate in Vancouver, Canada — where privacy regulators have an open investigation into its app. Among the listed cons in the one-star review is the claim that: “The well-being of patients is not seen as a priority. A real joke to healthcare. Best to avoid.”)
Per Watkins’ report of his online meeting with the MHRA, he says the regulator agreed NDAs are “problematic” and impact on the ability of employees to speak up on safety issues.
He also writes that it was acknowledged that Babylon employees may fear speaking up because of legal threats. His minutes further record that: “Comment was made that the MHRA are able to look into concerns that are raised anonymously.”
In the summary of his concerns about Babylon, Watkins also flags an event in 2018 which the company held in London to promote its chatbot — during which he writes that it made a number of “misleading claims,” such as that its AI generates health advice that is “on-par with top-rated practicing clinicians.”
The flashy claims led to a blitz of hyperbolic headlines about the bot’s capabilities — helping Babylon to generate hype at a time when it was likely to have been pitching investors to raise more funding.
The London-based startup was valued at $2 billion+ in 2019 when it raised a massive $550 million Series C round, from investors including Saudi Arabia’s Public Investment Fund and a large (unnamed) U.S.-based health insurance company, as well as insurance giant Munich Re’s ERGO Fund — trumpeting the raise at the time as the largest ever in Europe or U.S. for digital health delivery.
“It should be noted that Babylon Health have never withdrawn or attempted to correct the misleading claims made at the AI Test Event [which generated press coverage it’s still using as a promotional tool on its website in certain jurisdictions],” Watkins writes to the regulator. “Hence, there remains an ongoing risk that the public will put undue faith in Babylon’s unvalidated medical device.”
In his summary he also includes several pieces of anonymous correspondence from a number of people claiming to work (or have worked) at Babylon — which make a number of additional claims. “There is huge pressure from investors to demonstrate a return,” writes one of these. “Anything that slows that down is seen [a]s avoidable.”
“The allegations made against Babylon Health are not false and were raised in good faith in the interests of patient safety,” Watkins goes on to assert in his summary to the regulator. “Babylon’s ‘repeated’ attempts to actively discredit me as an individual raises serious questions regarding their corporate culture and trustworthiness as a healthcare provider.”
In its letter to Watkins (screengrabbed below), the MHRA tells him: “Your concerns are all valid and ones that we share.”
It goes on to thank him for personally and publicly raising issues “at considerable risk to yourself.”
Babylon has been contacted for a response to the MHRA’s validation of Watkins’ concerns. At the time of writing it had not responded to our request for comment.
The startup told the HSJ that it meets all the local requirements of regulatory bodies for the countries it operates in, adding: “Babylon is committed to upholding the highest of standards when it comes to patient safety.”
In one aforementioned aggressive incident last year, Babylon put out a press release attacking Watkins as a “troll” and seeking to discredit the work he was doing to highlight safety issues with the triage performed by its chatbot.
It also claimed its technology had been “NHS validated” as a “safe service 10 times.”
It’s not clear what validation process Babylon was referring to there — and Watkins also flags and queries that claim in his correspondence with the MHRA, writing: “As far as I am aware, the Babylon chatbot has not been validated — in which case, their press release is misleading.”
The MHRA’s letter, meanwhile, makes it clear that the current regulatory regime in the U.K. for software-based medical device products does not adequately cover software-powered “health tech” devices, such as Babylon’s chatbot.
Per Watkins there is no approval process, currently. Such devices are merely registered with the MHRA — but there’s no legal requirement that the regulator assess them or even receive documentation related to their development. He says they exist independently — with the MHRA holding a register.
“You have raised a complex set of issues and there are several aspects that fall outside of our existing remit,” the regulator concedes in the letter. “This highlights some issues which we are exploring further, and which may be important as we develop a new regulatory framework for medical devices in the U.K.”
An update to pan-EU medical devices regulation — which will bring in new requirements for software-based medical devices and had been originally intended to be implemented in the U.K. in May last year — will no longer take place, given the country has left the bloc.
The U.K. is instead in the process of formulating its own regulatory update for medical device rules. This means there’s still a gap around software-based “health tech” — which isn’t expected to be fully plugged for several years. (Although Watkins notes there have been some tweaks to the regime, such as a partial lifting of confidentiality requirements last year.)
In a speech last year, health secretary Hancock told parliament that with the government aimed to formulate a regulatory system for medical devices that is “nimble enough” to keep up with tech-fueled developments such as health wearables and AI while “maintaining and enhancing patient safety.” It will include giving the MHRA “a new power to disclose to members of the public any safety concerns about a device,” he said then.
In the meanwhile the existing (outdated) regulatory regime appears to be continuing to tie the regulator’s hands — at least vis-a-vis what they can say in public about safety concerns. It has taken Watkins making its letter to him public to do that.
In the letter the MHRA writes that “confidentiality unfortunately binds us from saying more on any specific investigation,” although it also tells him: “Please be assured that your concerns are being taken seriously and if there is action to be taken, then we will.”
“Based on the wording of the letter, I think it was clear that they wanted to provide me with a message that we do hear you, that we understand what you’re saying, we acknowledge the concerns which you’ve raised, but we are limited by what we can do,” Watkins told us.
He also said he believes the regulator has engaged with Babylon over concerns he’s raised these past three years — noting the company has made a number of changes after he had raised specific queries (such as to its T&Cs, which had initially said it’s not a medical device but were subsequently withdrawn and changed to acknowledge it is; or claims it had made that the chatbot is “100% safe” which were withdrawn — after an intervention by the Advertising Standards Authority in that case).
The chatbot itself has also been tweaked to put less emphasis on the diagnosis as an outcome and more emphasis on the triage outcome, per Watkins.
“They’ve taken a piecemeal approach [to addressing safety issues with chatbot triage]. So I would flag an issue [publicly via Twitter] and they would only look at that very specific issue. Patients of that age, undertaking that exact triage assessment — ‘okay, we’ll fix that, we’ll fix that’ — and they would put in place a [specific fix]. But sadly, they never spent time addressing the broader fundamental issues within the system. Hence, safety issues would repeatedly crop up,” he said, citing examples of multiple issues with cardiac triages that he also raised with the regulator.
“When I spoke to the people who work at Babylon they used to have to do these hard fixes … All they’d have to do is just kind of ‘dumb it down’ a bit. So, for example, for anyone with chest pain it would immediately say go to A&E. They would take away any thought process to it,” he added. (It also of course risks wasting healthcare resources — as he also points out in remarks to the regulators.)
“That’s how they over time got around these issues. But it highlights the challenges and difficulties in developing these tools. It’s not easy. And if you try and do it quickly and don’t give it enough attention then you just end up with something that is useless.”
Watkins also suspects the MHRA has been involved in getting Babylon to remove certain pieces of hyperbolic promotional material related to the 2018 AI event from its website.
In one curious episode, also related to the 2018 event, Babylon’s CEO demoed an AI-powered interface that appeared to show real-time transcription of a patient’s words combined with an “emotion-scanning” AI — which he said scanned facial expressions in real time to generate an assessment of how the person was feeling — with Parsa going on to tell the audience: “That’s what we’ve done. That’s what we’ve built. None of this is for show. All of this will be either in the market or already in the market.”
However neither feature has actually been brought to market by Babylon as yet. Asked about this last month, the startup told TechCrunch: “The emotion detection functionality, seen in old versions of our clinical portal demo, was developed and built by Babylon‘s AI team. Babylon conducts extensive user testing, which is why our technology is continually evolving to meet the needs of our patients and clinicians. After undergoing pre-market user testing with our clinicians, we prioritized other AI-driven features in our clinical portal over the emotion recognition function, with a focus on improving the operational aspects of our service.”
“I certainly found [the MHRA’s letter] very reassuring and I strongly suspect that the MHRA have been engaging with Babylon to address concerns that have been identified over the past three-year period,” Watkins also told us today. “The MHRA don’t appear to have been ignoring the issues but Babylon simply deny any problems and can sit behind the confidentiality clauses.”
In a statement on the current regulatory situation for software-based medical devices in the U.K., the MHRA told us:
The MHRA ensures that manufacturers of medical devices comply with the Medical Devices Regulations 2002 (as amended). Please refer to existing guidance.
The Medicines and Medical Devices Act 2021 provides the foundation for a new improved regulatory framework that is currently being developed. It will consider all aspects of medical device regulation, including the risk classification rules that apply to Software as a Medical Device (SaMD).
The U.K. will continue to recognize CE marked devices until 1 July 2023. After this time, requirements for the UKCA Mark must be met. This will include the revised requirements of the new framework that is currently being developed.
The Medicines and Medical Devices Act 2021 allows the MHRA to undertake its regulatory activities with a greater level of transparency and share information where that is in the interests of patient safety.
The regulator declined to be interviewed or respond to questions about the concerns it says in the letter to Watkins that it shares about Babylon — telling us: “The MHRA investigates all concerns but does not comment on individual cases.”
“Patient safety is paramount and we will always investigate where there are concerns about safety, including discussing those concerns with individuals that report them,” it added.
Watkins raised one more salient point on the issue of patient safety for “cutting edge” tech tools — asking where is the “real-life clinical data”? So far, he says the studies patients have to go on are limited assessments — often made by the chatbot makers themselves.
“One quite telling thing about this sector is the fact that there’s very little real-life data out there,” he said. “These chatbots have been around for a good few years now … And there’s been enough time to get real-life clinical data and yet it hasn’t appeared and you just wonder if, is that because in the real-life setting they are actually not quite as useful as we think they are?”
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