Dr. Oommen John, Senior Research Fellow, George Institute says, India is a hub for digital health innovations, however very few of these innovations have achieved the scale for impact within the health systems. It is important therefore to pause, reflect and use the WHO digital health guidelines as framework of the innovation ecosystem in India and help guide energy and enthusiasm of the start-ups to develop, evaluate and implement digital health innovations that can help achieve the universal health coverage.

The guideline encourages policy- makers and implementers to review and adapt to these conditions if they want digital tools to drive tangible changes and provides guidance on taking privacy considerations on access to patient data.

“Digital health is not a silver bullet,” says Bernardo Mariano, WHO’s Chief Information Officer. “WHO is working to make sure it is used as effectively as possible. This means ensuring that it adds value to the health workers and individuals using these technologies, takes into account the infrastructural limitations, and that there is proper coordination.”

Mr. Mariano also said: “Digital Health is the future of healthcare. As we take the big leap into digital health, we must ensure that it is people centric, delivers positive health outcomes, does no harm to people and it actually improves the healthcare system as a whole.”

It is a ‘Living Guideline’ i.e. it will be updated regularly as new evidence becomes available. This Guideline has been completed under the newly formed section at the WHO: Norms and Standards section in the WHO. This Guideline has been regarding: Reproductive Health & Research and has four outcomes:

• Health systems to have health data for accountability
• Helping health workers to work efficiently
• For tracking medical commodities to provide services
• Making sure health coverage for all

Since it is a developing guideline and is meant to be stringent based on evidence alone; it is a path finder for a whole gamut of health issues. For each recommendation, a summary of the evidence on the positive and the negative effects has been provided.

Dr. Garrett Mehl, Scientist, Digital Innovation and Research, WHO says: “Digital interventions depend heavily on the context and ensuring appropriate design. This includes structural issues in the settings where they are being used, available infrastructure, health needs they are trying to address, and the ease of use of the technology itself.” Importantly, it must be noted that: “Digital health interventions are not sufficient on their own.”

The guideline recommendations about telemedicine, which allows people living in the remote locations to obtain health services by using mobile phones, web portals, or other digital tools. WHO points out that this is a valuable complement to face-to-face- interactions, but it cannot replace them entirely. It is also important that consultations are conducted by qualified health workers and that the privacy of individuals’ health information is maintained. The guideline emphasizes the importance of reaching vulnerable populations, and ensuring that digital health does not endanger them in any way.

Trusted Exchange Framework and Common Agreement (TEFCA)

On 19th April 2019, US Department of Health and Human Resources (HHS’) announced the next steps in advancing operability of health information by opening up the second draft of the Trusted Exchange Framework and Common Agreement (TEFCA) for public comment. TEFCA, would support the full, network-to-network exchange of health information nationally. Specifically, the documents being released for comments are: (1) a second draft of the Trusted Exchange Framework (TEF), (2) a second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange, and (3) a first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHIN’s and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale, across disparate networks.

“The seamless, interoperable exchange of health information is the key piece of building a health system that empowers patients and providers and delivers better care at a lower cost,” said HHS Secretary Alex Azar. “The 21st Century Cures Act took an important step towards this goal by promoting a national framework and common agreement for the trusted exchange of health information. We appreciate the comments and input from stakeholders so far and look forward to continued engagement.”

In developing a TEFCA that meets industry’s needs, HHS’ Office of the National Coordinator (ONC) for Health Information Technology focused on three high-level goals:

• Provide a single “on-ramp” to nationwide connectivity
• Ensure electronic information securely follows you when and where it is needed; and
• Support nationwide scalability for network connectivity

ONC will maintain the TEF, while a non-profit, industry-based organization, known as the Recognized Coordinating Entity (RCE), will be awarded funds to develop, update, implement, and maintain the Common Agreement. Through this effort, ONC will define the minimum required terms and conditions needed to bridge the current differences among data sharing agreements that are preventing the flow of electronic health information. The industry-based RCE will be tasked with developing additional required terms and conditions necessary to operationalize the Common Agreement and meet the interoperability requirements of the 21st Century Cures Act.

“The updated Trusted Exchange Framework and Common Agreement we issued today considered more than 200 comments we received on our previous draft and reflects extensive work with our federal partners,” said Don Rucker, National Coordinator for Health Information Technology. “The future Common Agreement, made possible by the steps we take today, will provide the governance necessary to meet the interoperability demands of diverse stakeholders, including patients, healthcare providers, and health plans.”

The drafts released are responsive to stakeholder comments by making key changes to the draft requirements that health information networks who choose to participate would have to follow. These changes include updating the purposes for which information can be exchanged, adding a “push” method of data exchange, adding a technical framework for QHIN’s, and extending timelines for participating entities to implement changes that will be required by the Common Agreement.

These changes will help improve the flow of information between networks where needed and appropriate. In public health settings, for example, “reporting from providers is a foundational capability for effective public health action,” said Chesley Richards, Deputy Director for Public Health Scientific Services at the Centers for Disease Control and Prevention & that “The TEFCA will not only strengthen this capability, but will create the ability for timely and true bi-directional information sharing that is essential for responding to public health threats and epidemics.”

Designed to fill the gaps that currently impede the secure and appropriate flow of health information and to continue to enable the progress that has already been made in the private sector, the success of TEFCA depends on coordination with the private sector. “We expect that the implementation of the Trusted Exchange Framework and the Common Agreement, will bring us all that much closer to achieving the administration’s goals of nationwide interoperability,” said Dr. Rucker.

General Data Protection Regulation (GDPR), One Year On

It is a very recent piece of legislation in the European Union and the European Economic Area regions (continuation to the previous article on GDPR in InnoHEALTH volume 3 issue 1 Jan-Mar 2018). The GDPR was adopted on 14th April 2016, and became enforceable on 25th May 2018. As the GDPR is a regulation and not a directive, it is directly binding and applicable, but does provide flexibility for certain aspects of the regulation to be adjusted by individual member states. the UK granted royal assent to the Data Protection Act 2018 on 23rd May 2018, which contains equivalent regulations and protections as the GDPR.

After the first year of implementation of the GDPR over 200,000 cases have been reported. European data protection agencies have issued fines in excess of 55 million Euros for GDPR breaches since it was enforced last May, but this seems to be just the tip of the iceberg, thus making a strong possibility that enormous number of GDPR breaches are occurring but probably are yet going unreported. An assessment from the European Data Protection Board (EDPB) which is made up of regulators across the region, found that, in the first nine months, there were 206,326 cases reported under the new law from the supervisor authorities in 31 countries in the European Economic Area. One thing that has changed since the implementation of the GDPR is the massive increase in the reported number of incidents and more importantly that the companies have been reporting themselves to the data commissioner over the past year. The main emphasis under the GDPR Regulation is that companies must notify the regulators very quickly once the company losses any personal data. Consequently, of the breaches huge fines can be levied on the companies if they are found to have not done what they should have done to protect the personal data or specifically be able to display that they did all they could to clean up after the breach occurred in the first place.

Considering the developments all around the world, in terms of guidelines and regulations, specifically relating to the digital health, it is only right & more essential to emphasize the pressing need for India to have specific laws too for this area as practice carries on while laws don’t exist, which will result in exponential damage in the coming times.

About the author

Sapna Singh is a lawyer with years of experience in Telehealth law research. She possesses Diploma in Hospital Administration from India; Masters of Law in Intellectual Property Rights from US; Masters of Science in Telemedicine & ehealth from UK.

How can IoT deliver the much- needed booster shot to people living in the far-flung areas and hinterlands of the country?

Imagine rural folks sitting in front of an Internet-connected screen, listening to a doctor sitting in a Metro hospital who, basis on their heart test results, gives them sane advice to either go for specialty tests or resort to prescribed medicines easily found in the vicinity; or envision a city-based doctor looking at a patient’s chest X-ray and decides on the next course of action – all via connected network of IoT devices.

The benefits of IoT are multifold – in providing telemedicine, personalized healthcare, video-based consultations and future wellness strategies – without the patient leaving the village sans emergency.

The IoT infrastructure needs is reliable internet, low-cost IoT devices, security and data analytics and India is slowly picking up on these fronts.

Thanks to the 4G revolution, better Internet connectivity has reached most of the parts in the country, helping the stakeholders in the healthcare industry aim for the last-mile connectivity.

As far as low-cost devices are concerned, several IoT health start-ups have now come to the fore, and are set to change the course of the healthcare industry.

Since IoT is a concept of devices talking to one another, there is a lot of data transfer happening.

To make sense of the data, Artificial Intelligence (AI) and Machine Learning (ML)-capable solutions are already here which – with the agility, scalability and security of cloud – can give predictive analysis of a patient’s data in a jiffy to the doctor.

India’s IoT market size is expected to expand to $9 billion by 2020, according to market research firm Deloitte, and healthcare sector is going to be the main beneficiary.

In a country like India, building state- of-the-art hospitals at every nook and corner is a daunting task. Telemedicine, where patients sitting in remote areas are brought face-to-face to a city doctor via a laptop is the best option.

Therefore, a heart patient can begin talking to a specialist working in a super- specialty hospital in New Delhi, discuss reports, and together work towards whether the patient needs to visit a nearby District Hospital for further check-ups and come to the Capital for advance check-ups or medical procedures.

Once back after a medical procedure or a surgery, the rural patient need not go back again for follow-ups.

Now bring low-cost IoT devices into the picture and the data that is being generated, goes in the Cloud and reaches the doctor faster. This helps the specialist better understand the case and build an online repository of research for future references. The process of well-documented research has today made telemedicine very efficient.

In rural India, nearly 37 per cent of people have access to In-Patient Department (IPD) facilities within a 5-km distance and only 68 per cent have access to an Out-Patient Department (OPD).

Most patients in rural areas do not have access to specialists. Thus, several big hospital chains are offering remote consulting services in rural villages using IoT network capabilities. The doctors can see and interact with patients in remote telemedicine centers, with the case history and medical data automatically transmitted to the doctor for analysis. With the advent of new technologies, various state governments are now leaning towards IoT.

Take the example of the Telangana Government which is using Microsoft’s Cloud-based advanced analytics IoT solution to screen children from birth to 18 years of age for major conditions affecting their health. The data is useful to safeguard rural population. It provides the capability of applying ML and AI to cardio-vascular health records to develop an Indian-specific heart risk score. This data can provide rich insights to doctors on treatment plans and early diagnosis. Such solutions for diagnostics in rural India, with the help from Machine Learning algorithms, can accurately diagnose and predict conditions.

In a paper “IOT in Healthcare: A Study,” M Surya Prabha and B Sarojini from Avinashilingam Institute for Home Science and Higher Education for Women University in Coimbatore mention that IoT devices are being used in many hospitals for patient care and get their health details in India.

“IoT healthcare system connects all the available resources as a set of connections to perform healthcare activities such as diagnosing, monitoring, and remote surgeries over the Internet,” they note. The monitoring of the patients has become possible through the wireless solutions connected through the IoT. These solutions help to securely capture a patient’s health data from a variety of sensors, apply complex algorithms to analyze the data and then share it through wireless connectivity with medical professionals who can make appropriate health recommendations. IoT devices also boost patient’s confidence and satisfaction by allowing patients to get connected with their doctors virtually.

The concept of IoT, say the researchers, has been comprehensive to cover more type of devices such as Global Positioning System and mobile devices. Smartphones (India has over 450 million smartphone and over 700 million feature phone users) can be used to build an inclusive IoT network.The mobile devices can aid healthcare workers to diagnose, track and control infectious diseases.

There are now apps to help rural population. India’s largest online health camp called “myUpchar” recently launched a “Saathi” app. “myUpchar” partners in operating villages along with volunteers and support staff who collect basic details of the patients such as weight, height, blood pressure, glucose, pulse and temperature, and shares those on the app with the doctor.

A recent study published in the journal Nature found that people can make use of apps that employ the phone’s camera to interpret test results, and send them to local clinics or healthcare workers before being uploaded to a central online database.

Globally, the healthcare IoT market is expected to reach $72.02 billion by 2021. According to Nutanix, a global leader in cloud software and hyper converged infrastructure solutions, the healthcare organizations need to address a variety of critical IT needs, which include a need for increased security, protection of sensitive patient data and meeting regulatory compliance. From a patient’s and clinician’s perspective, adopting a cloud model, hybrid or otherwise, also allows for providers to undergo a digital transformation of healthcare delivery.

Infrastructure innovations allow hospitals to manage different appli- cations and data types, take advantage of automation and create new service lines such as telehealth or remote monitoring, thus leading to improved patient engagement. Healthcare companies outpace the averages for certain applications, such as data analytics and Internet of Things (IoT). The fact is that India has always looked to provide a premier healthcare system for its citizens. Thus, investing in the next generation IT and IoT infrastructure is the first step in preserving the current quality of care and bringing healthcare to all.

About the author

Meenakshi Iyer is a New Delhi-based freelance journalist covering health, technology and latest innovations. With more than 15 years of experience, she has worked with top media publications in the country.