Digital health round-up: NHS Digital, new patient monitoring tech, and Gilead

This week has seen the resolution of a policy that threatened to undermine public confidence in the NHS’s information and technology partner, NHS Digital. Richard Staines reports.

NHS Digital information-sharing agreement revised

Bowing to pressure from the public and politicians the government has revised its agreement that allowed NHS Digital to share non-clinical information with the Home Office.

The move follows many years of pressure from MPs, doctors and charities, all of whom have been concerned about the way personal information has been used to trace immigration offenders and vulnerable people.

This meant that NHS Digital could be asked to hand over information such as a person’s last known address, or their date of birth, to the Home Office.

MP Margot James, a minister at the Department for Digital, Culture, Media and Sport, said that the memorandum of understanding (MOU) has been amended “with immediate effect” in the wake of the Windrush immigration debacle.

“The aim is to narrow the MOU’s scope, so that it only facilitates the exchange of personal data in cases involving serious criminality,” she said.

The Royal College of GPs welcomed the news, saying that the previous arrangements undermined trust between patients and doctors.

PeraHealth patient monitoring tech gets FDA backing

Across the pond, groundbreaking technology from PeraHealth, that monitors patient health and flags up anomalies, has been given the green light by the Food and Drug Administration (FDA).

PeraHealth’s founders, Michael and Steven Rothman, were inspired to create the Rothman Index (RI) after the death of their mother, Florence. While she received good care after a low-risk heart procedure, the subtle changes in her condition were not picked up and she died, despite there being a wealth of data available.

The brothers approached the hospital in which their mother had been treated and found a way to bring together the electronic health record (EHR) and other health measures to help medics spot, and act on, any deterioration in a patient’s condition.

The result is PeraTrend, a predictive real-time clinical surveillance technology that improves patient outcomes by combining a patient’s EHR with measures that quantify and visualise patient deterioration, risk and improvement. It is already being used in hospitals and healthcare systems across the US.

PeraTrend is the first solution of its kind to be granted 510(k) clearance by the FDA, which means that the product – at this stage of premarket submission – was deemed at least as safe and effective as a legally-marketed device.

PeraTrend uses the RI to check on a range of physiological measures – including lab results, vital signs and nursing assessments – to produce a continuous measure of a patient’s condition across diseases, conditions and levels of care, with trends indicated before a situation becomes critical.

The RI provides a statistically validated patient acuity score across all diseases and conditions.

Michael Rothman, PeraHealth’s chief science officer and co-founder, said, “The FDA’s extensive validation steps provide further evidence of the Rothman Index as the clinical gold standard in measuring patient condition across the acuity spectrum.

“The model we created 10 years ago benefits thousands of patients every day and is backed by more than 40 peer-reviewed articles. PeraHealth will continue to research, innovate, and share strategies for enhancing patient-centred, value-based care, including mortality reduction and earlier identification of sepsis.”

Gilead and Verily partner on inflammatory diseases

Gilead has signed a three-year deal with Google’s life science division Verily to work on identifying the immunological and molecular drivers behind three inflammatory diseases.

The partners will look to better understand rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases.

Gilead said the work could guide its future drug discovery and development, specifically by identifying molecular signatures that may help physicians select the most appropriate treatment or dosing for a particular patient.

John McHutchison, chief scientific officer and head of research and development at Gilead, said: “Inflammatory diseases are complex and heterogeneous and, despite treatment advances, most patients experience neither deep nor long-lasting remissions.

“We are excited to be collaborating with the scientists at Verily to accelerate our understanding of these common and serious inflammatory diseases. We hope to ultimately improve patient outcomes using this cutting-edge technology to identify molecular disease pathways that would otherwise remain undetected.”

The data generated in this collaboration may also enable better characterisation of subtypes of inflammatory diseases, thereby helping researchers identify new molecular targets and perhaps new therapies.

The collaboration will see Verily use its Immunoscape platform to analyse biological samples and clinical disease and treatment response data from patients taking part in Gilead’s current and future phase 2 and 3 clinical trials.

Verily’s chief medical officer, Jessica Mega, said: “With the Immunoscape platform, we are seeking to develop a molecular map of inflammatory diseases that will help us identify and characterise disease mechanisms.

“This collaboration with Gilead is an incredible opportunity to learn much more about these immune-mediated conditions than ever before, and to hone in on potential paths to deliver more precise medicine to patients.”

Gilead and Verily were at pains to stress that they would respect patient confidentiality throughout the work, with all data and samples coded to protect patient privacy and any findings to only include patient data in aggregate.

Verily’s deal with Gilead adds to a roster of pharma partners that so far includes AstraZeneca in coronary heart disease, Biogen in multiple sclerosis and Sanofi on a range of diabetes management solutions.

The company is also working on a wide variety of healthcare projects, including a wearable designed for use in clinical trials called Study Watch, investing in Medicxi’s European life sciences investment fund, opening a cancer testing lab and even looking to map human health through Project Baseline.