Latest news with #MedicalDeviceNetwork
Yahoo
01-08-2025
- Business
- Yahoo
AI proliferation in healthcare shines light on HIPAA shortcomings
The use of artificial intelligence (AI) and generative AI (GenAI) in the healthcare space is skyrocketing. GlobalData analysis reveals that the AI market in healthcare is projected to reach a valuation of around $19bn by 2027. While the White House recently unveiled plans to 'remove barriers to American leadership' with an AI action plan, for now, entrants into the healthcare space providing AI tools to healthcare providers (HCPs), must comply with the US's Health Insurance Portability and Accountability Act (HIPAA), a regulation from 1996 that outlines rules around protecting patient healthcare data. Aaron T. Maguregui, partner at law firm Foley & Lardner told Medical Device Network: 'HIPAA was intended to scale with time and with technology. What I don't think HIPAA ever contemplated was the fact that AI would be able to essentially take in data from multiple sources, match it together, and create the potential for the reidentification of data that was never intended to be used for reidentification.' Technology has far outpaced regulation, and while Maguregui does not view HIPAA as being incompatible 'in and of itself', he states that it needs updating to account for the growing technology and compute power that exists, and how data is now being used to train AI. 'An AI vendor that provides a service to a HCP that is regulated by HIPAA is a subcontractor, and their role in healthcare is very regulated, and this becomes a somewhat limiting force for AI vendors trying to innovate and move the needle with their product, because their permitted usage and disclosures of the data as regulated by HIPAA is very restrictive,' Maguregui explained. 'It's restricted to the services that the vendor has agreed to provide, so any additional innovation, including, for example, additional training provisions the vendor may need, usually requires the HCP, and sometimes patients', consent.' Navigating HIPAA for HCPs and vendors Maguregui advises clients to start with a privacy impact assessment and bake in data governance from day one. 'On the provider side, it's important to know the types of data you have, who you're sharing data with, and what your responsibilities with respect to that data are,' Maguregui said. 'With virtual health exploding, and clinical intake going virtual, there are chatbots and workflows that are collecting data and information almost constantly, and it is important to understand whether information is regulated by HIPAA or by state law.' Having an awareness of these factors is especially important for HCPs that want to leverage an AI vendor, because they have to be able to communicate to that vendor what they need to comply with, because it will be the same regulation that the HCP has to comply with. Maguregui continued: 'In some cases, from an AI vendor's perspective, this may seem a bit unfair, because they have to rely on another party's assertion that they are complying with all of the laws they are required to comply with. 'The vendor then has to figure out whether they can comply with the relevant regulation and provide their service in compliance with the law and legally use the data at hand for purposes that are going to make their product better.' The direction of HIPAA regulation According to Maguregui, if the US cannot get on board with a single federal privacy legislation, then HIPAA should be expanded to cover the other entities that interact with health information. 'We have a desegregated regime in the US where the Federal Trade Commission (FTC) tries to regulate when HIPAA does not regulate, and that leads to more confusion and results in uncertainty for vendors and HCPs alike in understanding what their roles and obligations are,' Maguregui said. 'My wish for HIPAA would be to expand and update it, to understand where technology has gone, where compute has gone, and to improve the ability for innovation, the ability for vendors to have better access to data that will help them create better products, and to ultimately improve the patient and provider experience, and healthcare overall.' "AI proliferation in healthcare shines light on HIPAA shortcomings" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
03-07-2025
- Health
- Yahoo
Cognito achieves enrolment target in trial of Spectris system for Alzheimer's
Cognito Therapeutics has reached its enrolment goal for the randomised, sham-controlled HOPE Study investigating the Spectris AD system's efficacy and safety in treating Alzheimer's disease. The double-blind trial, with 670 subjects enrolled, is set to use the company's neuromodulating device at home for 12 months. Carried out across 70 US clinical sites, the trial will be followed by a 12-month open-label extension trial. According to the company, the Spectris AD system will deliver synchronised light and sound stimulation at the 40Hz gamma frequency, which has previously shown promise in the OVERTURE feasibility study by preserving corpus callosum structure in subjects with Alzheimer's. Results from the study indicated a 76% and 77% decrease in cognitive and functional decline, respectively, and significant white matter preservation with a 69% decrease in whole brain atrophy over six months. Subjects in the HOPE Study's treatment group will receive Active Sensory Stimulation System treatment once a day while the control group will use a Sham Sensory Stimulation System. Study visits for consent, screening, and baseline assessments are scheduled, followed by three, six, nine (by phone), 12, and 13 months safety follow-ups. The primary aim of the study is to evaluate Spectris' efficacy in slowing Alzheimer's progression against sham for mild to moderate patients, measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and the Mini-Mental State Exam (MMSE). A subset of clinical sites will participate in a substudy to assess additional fluid biomarkers. Subjects at these sites will undergo lumbar punctures to collect cerebrospinal fluid at baseline, three months, and 12 months. Cognito Therapeutics CEO Christian Howell said: 'Completing enrolment in this landmark trial marks a major step forward in our mission to deliver a better treatment option for people living with neurodegenerative conditions such as Alzheimer's.' The system remains investigational and is not yet available for sale. In 2023, Cognito secured $73m in Series B funding to further develop its wearable neuromodulation device for Alzheimer's. "Cognito achieves enrolment target in trial of Spectris system for Alzheimer's" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-06-2025
- Health
- Yahoo
Florida Cancer Specialists & Research Institute introduces liquid biopsy test
Florida Cancer Specialists & Research Institute (FCS) in the US has introduced liquid biopsy, a blood test that rapidly identifies cancerous tumours and circulating cells in the bloodstream. This test may be used to evaluate colorectal, lung, prostate, breast, and blood cancers. Liquid biopsy represents an advancement in cancer diagnosis and treatment, utilising a simple draw of blood to test for circulating tumour DNA (ctDNA). The introduction of liquid biopsy at FCS underscores the practice's focus on expanding its comprehensive genomic testing offerings, thereby improving diagnostic accuracy, guiding physicians in treatment decisions, and the patients' clinical outcomes. FCS claims to have broadened its testing options for the 250 physicians serving more than 102,000 individuals across Florida, since the introduction of next-generation sequencing (NGS) offerings at its centralised in-house laboratory in 2021. The practice has seen over 4.2 million annual visits and recently surpassed over 16,000 molecular tests processed at its Fort Myers lab facility. FCS genetics laboratory associate director Jennifer Gass said: 'Liquid biopsy is especially effective for providing genetic information quickly for various types of advanced cancers to help physicians assess and better target treatments that may work best and monitor patient response. 'Additionally, because it is minimally invasive and easy to repeat on an ongoing basis, liquid biopsy is significantly more comfortable for patients.' The expansion of the NGS testing menu at the FCS includes the addition of homologous recombination deficiency (HRD) testing, which analyses tumour DNA to determine potential treatment responses to poly (ADP-ribose) polymerase (PARP) inhibitors. This class of drugs specifically targets cancer cells. Other additions include a small heme NGS panel that identifies mutations related to myeloproliferative neoplasms and a quantitative assay for monitoring BCR-ABL gene fusions post-treatment in specific blood cancers. "Florida Cancer Specialists & Research Institute introduces liquid biopsy test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
06-06-2025
- Health
- Yahoo
LivaNova completes epilepsy treatment study of VNS Therapy
LivaNova has completed the CORE-VNS study, assessing outcomes via real-world evidence on the use of the VNS Therapy device in over 800 individuals with epilepsy. The study's final 36-month data confirms the therapy's effectiveness on severe focal seizures in paediatric and adult patients with drug-resistant epilepsy (DRE), showing early and sustained benefits. This open-label, long-term study enrolled participants from 61 sites around the world. The majority of the subjects, across all age groups, reported focal onset seizures with impaired awareness (FIA) as their most disabling seizure type. According to the study's data, for children aged four to 18, there was an 87% median reduction in FIA motor seizures at 36 months. Inclusive of adults, 34% of subjects with FIA motor seizures achieved 100% seizure minimisation, with an overall median decrease of 80%. Similarly, focal to bilateral tonic-clonic (FBTC) seizures saw a median reduction of 100% in children, and 49% of all participants with FBTC seizures reported complete seizure minimisation at their three-year study visit. VNS Therapy's effectiveness was observed as early as three months post-implantation, with further substantial decreases in both FIA and FBTC seizures observed at subsequent 12-, 24-, and 36-month visits. Notably, the CORE-VNS study claimed to have a high patient retention rate of 82% over the three-year follow-up period. LivaNova noted that VNS Therapy is an add-on treatment designed to decrease the seizure frequency in individuals aged four and above with DRE and partial-onset seizures. Involving an outpatient procedure, the implantation of this therapy does not involve skull penetration. The outcomes of the 36-month CORE-VNS study are set to be published later in the year. LivaNova Global Medical Affairs vice-president Kathryn Nichol said: 'LivaNova is deeply committed to advancing epilepsy research and in every study of VNS Therapy to date, we continue to see that effectiveness can be achieved early and continue to improve month by month and visit by visit. This remained true over the course of three years in CORE-VNS.' Last year, the company reported positive predictive outcomes from the OSPREY study of the aura6000 hypoglossal nerve stimulator system for treating obstructive sleep apnoea. "LivaNova completes epilepsy treatment study of VNS Therapy" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
05-06-2025
- Business
- Yahoo
Intravascular lithotripsy: market competition and clinical potential: new issue of Medical Technology out now
The field of Intravascular lithotripsy (IVL), a medical procedure that uses ultrasound shockwaves to break down calcified plaque in arteries, particularly those in the coronary arteries or peripheral arteries, is generating increasing levels of interest. This month's cover feature looks at the clinical promise IVL holds beyond the financial buzz it has generated in recent times. This issue also features analyst comment on the impact Trump's tariffs are having on the medical device industry, with companies moving to stockpile equipment in certain areas. Don't miss our two interviews out of Biomed 2025, which recently took place in Tel Aviv, Israel in May, with each featuring insight into how the bioconvergence and neuromodulation markets are continuing to develop globally. All this and the latest medtech industry news, comment, and analysis from GlobalData. If you like our magazine, sign up to have each issue delivered to your inbox. "Intravascular lithotripsy: market competition and clinical potential: new issue of Medical Technology out now" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
