SAM selects the target population on the following criteria:
Targeting vulnerability: SAM works with the poor and vulnerable communities who lack education, income, assets, status and access to healthcare.
Targeting pregnant, infants and children: SAM follows all pregnant women, infants and children under 5 years in the community.
Targeting reproductive age: For population stabilisation, SAM targets reproductive age group women and married couples between ages 18 and 49 years and adolescent girls from 10 to 19 years.
Targeting disease: SAM targets the families and contacts all TB patients, malnourished children and high-risk pregnant women.
SAM-ESP Innovation: SAM has developed a cost-effective platform for changing health behaviour ofa community. Health activists, in partnership with local public and private healthcare stakeholders, convert awareness to actionable knowledge. SAM has successfully used its Effective Social Persuasion Platform (SAM-ESP) in multiple locations. ESP relies on seven assumptions.
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Behaviour modification is the least expensive way to reduce disease burden.

Health is an individual and community responsibility; ownership of this responsibility empowers a community to demand healthcare rights. A campaign to push health information may improve awareness but is not sufficient by itself. Awareness is just one of many steps to change behaviour. Other essential steps include: a sustained, intensive, repetitive campaign without a predefined end time-point, encouraging peer to peer nudge and a methodical transfer of ownership to the community leaders.

Messages scripted by the community encourages their ownership. Trained volunteer activists can lead and sustain the ESP without external help.

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An established SAM-ESP platform can be used to address multiplehealth problems. SAM-ESP is not yetanother awareness building program. Awareness is often assumed to be equal to behaviour change. In practice, it is not true. Communication programs and prevalent awareness programs merely touch the surface without translating into significant behaviour change. SAM-ESP is a multi-step process, where awareness in just one of many steps for a sustainable behaviour change.

SAM promotes community ownership of both health and healthcare. SAM believes, that health is an individual and community responsibility and getting healthcare, as a right, has to be learned. SAM-ESP is a peoples’ program, which ensures that the health system is responsive and accountable.

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SAM trains volunteer health activists who lead the program and develops a cadre of social entrepreneurs, who sell contraceptives, sanitary pads and nutritional products. SAM field workers are from the community where they live and work. They are available 24/7 and take health to the doorstep of the recipients. The program sets no predetermined end date; repetitive training continues till SAM meets the objectives.

The following steps describe its execution:

Organize, create structure and build leadership capacity: SAM has well-trained field staff and managers;the voluntary directors of the organization are professionals from healthcare and management. Each district has a manager, trainers, and supervisors who are selected from the local population. They receive intensive training not only in health issues but also in motivational techniques, training methods and leadership.

Develop messages: SAM believes that a good message should be simple without technical jargon, short with less than five points, easy to understand without explanation and emotionally connected with a local need. For better retention, a message could be in the form of a story, song or a slogan. Some messages should be created by the community to feel ownership.

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Train health activists: Master trainers train volunteer health activists to be responsible for village health issues. Training is repetitive and intense.

Teach people: SAM organizes the village into a healthcare community. Field supervisors motivate and mobilize villagers and discuss each topic of healthcare with a specific training module. SAM uses local community resources to create training material and health leaders script their own songs and slogans. Activists meet villagers repeatedly to discuss best practices. Repetitive training of health activists and villagers is essential.

Cooperation with public and private health systems: SAM establishes linkage with the local private and public health system. Utilizing all available public health resources is an essential component of the program. Public health workers are invited to all meetings. This linkage creates awareness, which improves demand of healthcare and encourages accountability.

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Evaluation and improvement: Programs are monitored by community involvement and by participatory research action. Results lead tocourse correction.
Replicate: Solutions are validated and replicated in other locations.

Measuring impact: Each program starts with a baseline and finishes with an end-line evaluation. SAM defines objectives, activities, outputs and outcomes before the start of the program. They measure monthly progress against all these parameters.

Process of measuring impact is a four-step process:
Data Collection at community level: The field workers collect data during house visits and community meetings. They upload it on a smartphone.
Data review at block level: Field officers collate and review data every month at a block level. They validate it through client interaction.

Data validation at district level: SAM validates data through a monitor and evaluation protocol which includes field visits, focus groups and comparison with public health data. SAM compares outcomes and impact with similar programs run by the government and other private organisations.

External agency evaluation: Periodically, SAM engages external agencies to evaluate its work. The funding partners also send external evaluators to check the progress and impact.

Direct impact: Since inception, SAM has trained 37,000 volunteer health activists who live in the villages and are available to the community. SAM has directly impacted over 1,150,000 million people through maternal, child health, population stabilisation and TB control programs.

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Through maternal, child health and population stabilization programs, SAM has directly impacted: 530,000 women and over approximately 100,000 infants. SAM follows all (100%) pregnant women in the villages and has reduced maternal mortality by 90% and infant mortality by 60%. In some places, SAM has done even better. In the past 6 years, in 167 villages of Gadag, Karnataka; maternal mortality rate has decreased to 15.8 from 364 and the Infant mortality rate has decreased to 5 from 46.

Through population stabilizations program, the marriage of girls under 18 years of age has decreased to almost zero. Contraceptive use has increased from 28% to 62% and supplychain management has reduced the unmet need for contraception from 10.8 % to 2% been running in 700 villages. 287,042 people have participated in 14,552 community meetings. 13,973 people have had sputum tested. Sputum was positive for TB in 1329 people and 14 had multiple drug resistant TB. All received supervised treatment. SAM has directly helped with education and surveillance of 130,000 contacts of TB patients and helped another 317,000 community members with awareness program. TB detection rate has improved 3.7 times.

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Indirect impact: SAM estimates that approximately 0.9 to 1 million people, who did not actively participate in its programs, became aware of the benefits from those who attended our programs.

Women feel empowered, which has opened their minds to many choices in life. They express their opinions freely. Men and elderly women, who were suspicious and objected to their women attending public meetings, have mellowed their resistance and have even become enablers. Girls attend school more regularly and the number of girls attending college has increased. Adolescents participation has increased. Public health system and their workers are more responsive to public demand.Local elected politicians are responsive.

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Discussion: Multiple theories have attempted to explain the health behaviour of individuals. The most popular is the Health Belief Model (HBM), which was developed about 40 years back. It postulates that people make healthcare decisions based on perceived susceptibility to disease and consequences. The response is tempered by perceived benefits of action and with a belief that benefits outweigh risks. While this theory, like other theories, builds a plausible reference point to explain behaviour, it gives no guidance for modification of individual behaviour.

Theory of Planned Behaviour suggests that a person should be empowered with ability (self-efficacy) to change behaviour. The person should believe that the behaviour will improve his health and is socially approved. It has also been recommended that principles of marketing could be applied to a social cause, where the product to be sold is behaviour change.

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SAM model comes close to a hybrid variety of HBM, building self-efficacy and social marketing. SAM tries todevelop social efficacy through the agency of health activists by using techniques similar to social marketing. SAM Effective Social Persuasion is a people’s platform, which needs further elucidation and expansion. SAM is looking to use entertainment education or gamification for behaviour modification and use of technology in early detection of noncommunicable diseases. SAM seeks collaboration with others for mutual learning, sharing resources and scaling-up the program in vulnerable population.

About the author

Dr. Shiban Ganju is the Chairman of Atrimed Pharmaceuticals and Founder of Save A Mother Foundation, USA. He has dedicated his life to healthcare. Dr. Ganju graduated from AIIMS New Delhi and received advanced training in Internal Medicine and Gastroenterology both in India and USA. He is a consultant specializing in gastroenterology, liver disease and nutrition in hospitals in the greater Chicago area. His commitment to and understanding of how to drive improvements in health outcomes has benefitted big strata of society.

Lt General (Dr.) Rajesh Pant is an internationally recognized Cyber Security expert, presently tenanting the prestigious appointment of National Cyber Security Coordinator at the Prime Minister’s Office, India. General Pant brings to the table an interesting mix of military operations, academic excellence, corporate governance, and cybersecurity wisdom. Prior to this, he was the Head of the Army’s Cyber Training establishment for three years. He served in the Army Signals Corps for 41 years wherein he was awarded three times by the President of India for distinguished service of the highest order. He also served as the Chairman of Precision Electronics Ltd as a Governing Council Member of IETE (India). Sachin Gaur interviewed him on his viewpoint on India’s vision for cybersecurity.

Q. On behalf of InnoHEALTH Magazine, we congratulate you on your new assignment. For our readers, we would like you to share your short-term and long-term vision for Cybersecurity from national security perspective.
Short-term vision is to issue National Cyber Security Strategy 2020-25 early next year. Task force is working overtime on this by consulting all stakeholders. Long-term vision is to create an all-encompassing cyber vertical at the national level, to handle incident response, cybercrimes, legal issues and capacity building.

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Q. We know that there are some fundamental technological shifts waiting to happen like 5G, and along-with it massive (Internet of Things) IoT deployments and especially use cases of connected healthcare. Can you share your views on the cybersecurity implications of the connected devices?
IoT security is a priority topic world over and this is because the limited security capabilities of these devices are also an afterthought. We need to work on a framework, to bring baselinesecurity through the manufacturers and developers of these devices. These devices are omnipresent in our lives, we find them in our home environment to industrial environments including hospitals. We have seen attacks in the past, where such devices are compromised to launch massive denial of service attacks to manipulate the workings of critical infrastructure.
Also, the issue of IoT security is multidimensional, from data security, privacy to device security. As we discuss this, there are multiple acts and bills pending in the Parliament on these topics. While the bills and acts will provide a framework, we need to also create awareness on both sides, supplier and consumer on the possible risks and mitigation strategies.

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Q. What steps can be taken to improve the security in such connected devices?
When I say baseline security framework, it can be achieved in multiple ways.
As of today, most devices that we use including mobile phones, do not have a security testing certification. So, we can agree with the industry and look at important test cases and if they can do self-certification on such test cases.
For example: the device should not have weak default login credentials, it is sending data to a remote server and can be operated remotely. So, we can come up like a 5-star rating framework like that of the energy consumption but for the security of IoT devices basis what kind of tests they clear.
Industry bodies can agree on various levels of security and what it takes to achieve that level. Such a framework, when implemented, can provide confidence to consumers and users on the kind of device they are using vis-a-visthe use case they have at hand. So, they might use a higher security rating device in a use case where the stakes are high.
The other approach is to get the security testing done with notified agencies. Department of Telecom for example has announced mandatory security testing of network elements for telecom given telecom is a part of the critical infrastructure and security issuescannot be taken lightly.
Also, some of the emerging concepts in connected devices are missing in the various governing acts of the industrial connected devices. So, we also need to update our legal frameworks to cover software-based tempering of such devices and make the manufacturers and service providers accountable and proactive towards the security of the systems they provide.

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Q. What are the threats that you foresee for the health sector?
There are three areas we see where health sector can be impacted:
First is the data breaches and ransomware attacks on healthcare data. As we know, among all the data, healthcare is the most sensitive and sought after by malicious actors. Outside of India, we have seen umpteen cases where ransomware has crippled the health system and it is only after paying the ransom the hospitals can start operation again. Timely backups and encryption of healthcare data during storage is a preventive measure that clinical establishments can take to mitigate the breach and ransomware attacks.
Second is the manipulation of connected devices. The topic of IoT and connected devices security, as discussed in the above sections, directly apply to the medical devices. Healthcare is a domain where attacks on such devices can be life threatening, especially when there are implantable devices. As we have the new Medical Device Regulation Act in India since 2018, we should also consider cyber security aspect in the devices which have a communication interface. For example, a pacemaker which has a communication interface can be manipulated remotely and the patient’s life is at risk.
Third is the manipulation of health system including the building management. We are probably not very far from the days when sophisticated attacks, as we see in the movies, on high security establishments by manipulating the building controls. The building management systems are very weak when it comes to security. Every hospital is a building and imagine what a false fire alarm would mean to patients in Intensive Care Unit. Or even loss of air conditioning or sudden spikes in electrical power.
There is a proposed act DISHA, Digital Information Security Healthcare Act, which might address some of the legal aspects of security in the healthcare setting. A lot needs to be done in this area, and we are on our way.

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Q. Our readership consists of health experts all over the world. Any message for them?
We are at the cusp of a new age where we look to take advantage of Artificial Intelligence to Internet of Things. For such a knowledge economy to take off, health sector is at the center of it and health experts need to pay attention on what they are buying and how such systems are managed and operated. Through intervention of Ministry of Health & Family Welfare and responsible bodies such as National Accreditation Board of Hospitals & Healthcare Providers (NABH) of Quality Council of India, we plan to recommend a cyber audit and increased awareness of information security.
We would not want our hospitals and clinical establishments to be a prey for malicious actors. Rather we would want our experts to leverage technology to take the country to the next level in providing care to a wider population at a lower cost and of the highest quality.

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.