The National Digital Health Mission, that Prime Minister Narendra Modi announced on Independence Day address, is envisioned as the first step towards Universal Health Coverage.

A digital health ecosystem will be put in place, complete with a personal health ID for every Indian, identifiers for doctors and health facilities and personal health records. All of this will be accessible through an app or a website with the health records “ownership” lying with the individual, as ThePrint had been the first to report on 23 July.

To be led by the National Health Authority that is also the administrative authority for the Pradhan Mantri Jan Arogya Yojana, the Rs 144 crore National Digital Health Mission (NDHM) will need all government health programmes, such as Ayushman Bharat and the tuberculosis programmes, to integrate with it and issue health IDs to beneficiaries.

While the health ID is not mandatory, the government is hoping that the feature will attract more users to it since it allows a person online access to all their health records right from birth. There will be an option of the ID being linked to Aadhaar but it will not be mandatory unless the person wants to avail of any government subsidy scheme.

According to its strategy document, the NDHM’s vision is: “To create a national digital health ecosystem that supports universal health coverage in an efficient, accessible, inclusive, affordable, timely and safe manner, that provides a wide-range of data, information and infrastructure services, duly leveraging open, interoperable, standards- based digital systems, and ensures the security, confidentiality and privacy of health-related personal information.”

In its first phase, the mission will pilot in Andaman & Nicobar Islands, Chandigarh, Dadra & Nagar Haveli and Daman & Diu, Lakshadweep, Ladakh and Puducherry. According to the original schedule, this was supposed to have started before the prime minister’s announcement, but there is a slight delay now and officials are hoping to get it off the block by the end of August.

The strategy document that was approved some time back says: “Phase 2 will be taking forward the pilot in additional States and expand the service bouquet. Phase 3 will target nation-wide roll-out, operationalizing and converging with all health schemes across India along with promotion, on-boarding, and acceptance of NDHM across the country.”

Safety and privacy of health data

Theoretically, health data is generated every time a doctor writes a prescription, every time an individual self medicates and every time the person undergoes a diagnostic test. Most of this data currently either exists in cumbersome and poorly kept files by patients, is not recorded or simply lost. The mission will require doctors/hospitals to upload a digital copy of any health reports being physically shared with the patient to enable creation of longitudinal health records.

“NDHM will implement a federated health records exchange system that will enable patient data to be held at point of care or at the closest possible location to where it was created. Health records will be accessible and shareable by the patient with appropriate consent and complete control of the records will remain with the patient,” says the strategy document.

“An appropriate digital consent framework as per standards specified by NDHB (leveraging DigiLocker consent management framework to the extent possible) will be adopted for consent management,” it further outlines.

Electronic Medical Records (EMR) — This refers to systems that are used within a hospital or a clinic to support patient diagnosis and treatment and are transaction focused. NDHM requires these systems to be updated to support standards and provide access to patients’ data.

Electronic Health Records (EHR) — EHRs contain records for a patient across multiple doctors and providers and is used within a Healthcare system (like say across a state government) to provide better care for patients.

Personal Health Records (PHR) — PHRs enable patients to compile, update and keep a copy of their own records that can help them better manage their care and are person focussed.

It will not be possible to have access to digital health records without creation of a health ID.

Governance structure

The mission will keep two separate arms, according to the National Digital Health blueprint. One arm will be for regulation and other for implementation and operational management. The Mission Steering Group, under the chairpersonship of the Union health minister, will oversee and guide the NDHM. Its members will include ministers of women and child development, social justice and empowerment, AYUSH and information technology, the principal scientific advisor, Member Health (NITI Aayog), secretaries of health, expenditure and information technology, the National Health Authority (NHA) CEO and others.

An Empowered Committee will be set up under the chairpersonship of the health secretary, that will take necessary policy-level decisions, help the mission with coordination with different stakeholders and engagement with different ministries and departments to ensure their participation. Its members will include NITI Aayog CEO, secretaries of women and child development, social justice & empowerment, MeitY, AYUSH, and expenditure as well as NHA CEO and directors general of health services and the National Informatics Centre.

Trials of a revamped NHS Test and Trace app have kicked off with residents on the Isle of Wight and NHS Volunteer Responders across England.

Tech giants Google and Apple worked with the NHS to develop the new app, after the pilot of an earlier version using Bluetooth was abandoned for having a poor success rate in tracking proximity to other devices.

The new app is designed to log the time and distance a user has spent near to anyone, so it can alert them if that person later tests positive for COVID-19.

Features include alerts to let users know the level of risk in their postcode district, a QR check-in alerting users if they have recently visited a venue where they may have come into contact with the virus, a symptom checker, test booking and a self-isolation timer.

To protect people’s privacy, the system generates a random ID for an individual’s device, which can be exchanged between devices to monitor the spread of the virus while rotating frequently to prevent tracking.

Following the initial trial, the app will be rolled out to residents in the London borough of Newham from next week.

UK charity, The Health Foundation has called on the government to ensure the trials are properly evaluated and findings are shared, saying that the ultimate test for the app will be whether it increases the proportion of contacts traced.

According to the latest statistics, the Test and Trace service is reaching more than 79% of all those who test positive, and 83.4% of their contacts where contact details were provided.

WHY IT MATTERS

The app aims to negate the need to know the contact details of people in order to warn them that they have been in contact with someone who has tested positive.

THE LARGER CONTEXT

Alongside Google and Apple, the Trace and Track programme has worked with scientists within the Alan Turing Institute and teams in countries across the world such as Germany using similar apps.

Last week, Northern Ireland became the first country in the UK to deploy a contact-tracing app. The Scottish government also announced that its app will be launched in Autumn.

Meanwhile, Norway’s contact tracing app Smittestopp was temporarily banned in June due to privacy concerns from the Norwegian Data Protection Authority.

ON THE RECORD

Executive chair of the NHS Test and Trace Programme, Dido Harding, said: “By launching an app that supports our integrated, localised approach to NHS Test and Trace, anyone with a smartphone will be able to find out if they are at risk of having caught the virus, quickly and easily order a test, and access the right guidance and advice.”

GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company announced the launch of GenomeXpress, a rapid genome sequencing test. Verbal GenomeXpress results of pathogenic and/or likely pathogenic variants in known disease causing genes are delivered to the ordering healthcare provider within approximately seven days after the start of testing. A written report for all confirmed variants is sent to the provider within approximately 14 days after start of testing. With the addition of GenomeXpress, GeneDx expands its industry-leading clinical genomics portfolio to now include three rapid sequencing options.

Genome sequencing is a test used to identify variations in any part of the genome and is an important tool for diagnosing genetic diseases. By including both protein-coding and non-coding regions of the human genome including promoter, intronic, and untranslated regions, GenomeXpress allows for the detection of characterized/pathogenic variants in regions that are not assessed by exome sequencing. Genetic changes can cause over 13,000 different diseases and patients often present with overlapping symptoms.1 Finding the correct diagnosis is not always straight-forward and may require multiple tests, costly evaluations, invasive procedures and long hospital stays. A rapid diagnosis can alter management, shorten the length of hospital stays, reduce healthcare costs and save lives.

“With the new offering of GenomeXpress, we are advancing healthcare,” said Jane Juusola, Ph.D., FACMG, Director of Clinical Genomics for GeneDx. “Rapid genome sequencing paired with GeneDx’s massive and ever-expanding genomic database provides clinicians, patients and their families with more meaningful information. As our database grows, we are better able to distinguish likely pathogenic variants from likely benign variants and subsequently identify new disease-causing genes. Every patient who receives a GenomeXpress test will benefit from both our current and future knowledge of genetic disease.”

“New and emerging scientific understanding is an imperative aspect of genomics,” said Adam Logal, President of GeneDx and Chief Financial Officer of OPKO Health. “Leveraging GeneDx’s diverse database with a rapid genome sequencing test may provide patients and their families with options they did not have before. GenomeXpress utilizes GeneDx’s clinical genomics expertise, laboratory excellence and the limitless value of the genome, as a future-facing sequencing technology.”

Genome sequencing has a diagnostic utility of 42-73%1-6 with a higher yield for cases that specifically include other family members.2,5,7-11 With a clinical utility of greater than four times that of chromosomal microarray, genome sequencing should be considered a first-line genomics test for children with suspected genetic diseases.2

About GeneDx, Inc.
GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc.

About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

Medtronic plc, the global leader in medical technology, announced the planned acquisition of privately-held Companion Medical, manufacturer of InPen — the only U.S. FDA-cleared smart insulin pen system paired with an integrated diabetes management app on the market. The addition of Companion Medical’s InPen to the Medtronic portfolio expands the company’s ability to serve people where they are in their diabetes journey and offer them a unique and expansive ecosystem of support — regardless of how insulin is delivered.

“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI). We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual. This smart CGM system can help people think less about diabetes and be able to live life with more freedom, on their own terms,” said Sean Salmon, executive vice president and president of the Diabetes Group at Medtronic. ”Our goal is to become a trusted partner that offers consistent support whether an individual wants to stay on MDI, transition to automated insulin delivery or take a break from their pump.”

The acquisition of Companion Medical builds upon prior Medtronic strategic acquisitions, including Nutrino and Klue, that form the building blocks to design powerful algorithms leveraging the company’s deep data science and AI capabilities. With this latest acquisition, Medtronic will work to further advance the automation of insights and dosing capabilities to help alleviate burden regardless of the technology that’s preferred for insulin delivery. In addition, Medtronic will look to expand the availability of InPen globally.

“We are thrilled to be combining our strengths and differentiated product portfolios to work towards serving even more people around the world living with diabetes in the ways that matter most to them,” said Sean Saint, CEO and co-founder of Companion Medical. “Simplifying diabetes management to reduce burden and improve outcomes has always been our goal, and through a respected global leader like Medtronic, we’ll now be able to take InPen to this next phase of growth which is great news for people with diabetes who stand to benefit most.”

The acquisition is expected to close within one to two months – subject to the satisfaction of certain customary closing conditions. The transaction is expected to be neutral to Medtronic’s adjusted earnings per share in the current fiscal year, and accretive thereafter. In addition, it is expected to meet Medtronic’s long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.

About Companion Medical
Companion Medical was founded by people with diabetes, which fuels our drive to create insulin technologies that enable users to live their lives with diabetes solutions that make sense – for them. The InPen is the only FDA-cleared, smart insulin pen system that combines the freedom of a reusable Bluetooth® pen with the intelligence of an intuitive mobile app that helps users administer the right insulin dose, at the right time.

About the Diabetes Group at Medtronic 
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.

About Medtronic
Medtronic plc , headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Thirty Madison, which operates three brands for hair loss, migraines and acid reflux, raised $47 million in a series B round. Polaris Partners led the round, and Johnson & Johnson participated as an investor.

With direct-to-consumer health brands Hims and Ro surging to high valuations, a new telehealth startup is entering the field with two big backers. New York-based Thirty Madison, founded just three years ago, raised a $47 million series B round led by Polaris Partners and with participation from Johnson & Johnson Innovation Inc. Previous investors Madison and Northzone also participated in the funding round.

Thirty Madison operates three brands focused on different conditions. It launched its first brand, Keeps, in 2018, offering prescription and over-the-counter hair loss treatments. Last year, it launched two additional brands, offering treatments for migraines and acid reflux.

Thirty Madison connects patients with a virtual physician consultation, and then offers medications on a monthly or quarterly subscription basis. All of its brands are self-pay.

“For this latest round of funding, it was important for us to continue to build support and alliances in the healthcare space and bring in some of the best healthcare-focused investors into the fold,” Thirty Madison CEO and Co-Founder Steven Gutentag wrote in an emailed statement. “This new capital will enable us to continue developing and iterating on our current brands, further invest in our platform, and expand into new therapeutic areas.”

Polaris Partners Managing Partner Amy Schulman will join Thirty Madison’s board of directors with the funding round. She previously led Pfizer’s $4 billion consumer healthcare unit and will bring her commercial expertise to the startup.

While Johnson & Johnson wasn’t a lead investor in the series B round, the drugmaker’s participation in the startup’s funding round is also notable.

“We understand that each company is unique and requires a distinct investment strategy, and we believe strongly in value-add investing and playing an active role in the companies in which we invest,” Stacy Feld, head of Johnson & Johnson Innovation for West North America, Australia and New Zealand, wrote in an emailed statement. “Our investment in Thirty Madison aligns with our overall strategy to bring new healthcare products and solutions to the people who need them most – in this case where current gaps exist for those suffering from chronic health conditions.”

Thirty Madison hasn’t said what areas it will expand into next, but its newer additions focusing on migraines and acid reflux are a departure from those offered by its competitors.

The startup also says its patients get to keep the same doctor through ongoing treatment, who they can message for follow-up questions.

At the same time, direct-to-consumer pharmacy companies have been pushing deeper into telehealth. Hims recently rolled out telepsychiatry services, and Ro has said it plans to expand into virtual urgent care visits and remote patient monitoring.