Patient-Owned Health Data Registries –
India Feasibility Study Report
Using a combination of literature surveys and stakeholder interviews, the authors evaluated India’s rare disease landscape and the barriers to enabling patient-owned health data registries for national and international data sharing.
Using a combination of literature surveys and stakeholder interviews, the authors evaluated India’s rare disease landscape and the barriers to enabling patient-owned health data registries for national and international data sharing.
While there is poor understanding among the general public about rare diseases, newer genetic technologies for diagnosis as well as the benefits of data sharing, different stakeholders have expressed interest in participating in a patient-owned rare disease registry and the main concerns raised were regarding data privacy and social stigma around rare diseases.
India currently has very few standardized registries, which are largely not patient-owned. India also does not have a Rare Disease Policy and there are no specific guidelines or regulations regarding collection and storage of data pertaining to patients with rare diseases. However, the country is moving towards digitizing healthcare with the newly launched National Digital Health Mission (NDHM). The program, among other things, provides a framework for decentralized storage of patient owned data. Data standards and CDEs to be used for all health-related applications are well defined in the Meta Data & Data Standards documents from the Ministry of Health and Family Welfare. India does not have legislation protecting patient-data privacy such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States, and the General Data Protection Rules (GDPR) in Europe. However, the Personal Data Protection Bill, which is not yet approved, allows patients control over their data and sets forth responsibilities for data users.
Given the current scenario in the country, patient-owned data collection efforts (registries) will benefit from the current trend of digitization and increased public awareness of health data. The authors recommend the pilot of a patient-owned rare disease registry in India and scale up in a gradual and dynamic manner allowing room to incorporate newer policies and laws that are underway.
AIMS OF THE FEASIBILITY STUDY
This initial phase of the project aims to conduct feasibility assessment for RARE-X in India and create a scoping document that will assess the opportunities to support patient-owned data collection in country. Steps of the study include:
1. Analysis of the landscape of rare diseases in India to understand current unmet needs from the perspective of patients and patient groups, and organizations, serving the rare disease community.
2. Analysis of the current regulatory and legal frameworks in India which are pertinent to patient data collection and sharing.
3. Interviews with stakeholders to assess interest and potential roadblocks for participation in a patient-owned data collection registry pilot:
a. Feasibility assessment of an universal or commercial IRB for India pilots, and consider that all patients data collection needs to happen under an IRB approved protocol with proper informed consent and data privacy or security compliance equivalent to HIPAA and GDPR.
b. Review existing natural history data from PAGs in order to assess the quality and feasibility of importing or interfacing between various data.
c. Understand willingness of PAGs to participate in Natural History study, and to gather initial letters of commitment where feasible.
d. Identify potential investigators to develop India-specific protocols & guide the disease-specific data elements & collection methods. Gather initial letters of commitment where feasible.
e. Assess the extent of support available or gaps in operationalizing sharing of patient-owned data to advance R&D.
f. Understand regulatory support or roadblocks to consider for execution of this India pilot.
4. Develop strategy for education and outreach to patient advocacy groups on the importance of data, quality, privacy, and processes to address the significant lack of understanding of the need for and methods of collecting high quality data.
5. Discuss and define Common Data Elements (CDEs), data formats, standards in practice, recommendations on consistent and standardized collection of quantitative versus qualitative data and impact on data quality.
The projected timeline was estimated prior to the COVID-19 pandemic which has resulted in changes in strategy and slight time line shifts. The pandemic has impacted the team’s ability to interact with stakeholders, and all interviews were conducted online. It probably has also affected the response from candidate interviewees, due to altered workloads and schedules especially for physicians and regulatory representatives. The authors wish to also note that the project timeline was impacted by unavailability of KOLS as the last month overlapped with the holiday season.
1. Literature Review: An initial survey was conducted of existing information on the landscape of rare diseases, patient registries, and collection and sharing of health data. This includes a detailed review of scientific and regulatory literature.
2. Rare Disease Stakeholders Mapping: An initial list of candidate interviewees was made to include the following key classes of stakeholders. The team tapped into its existing network of rare disease stakeholders in India. Additional candidates were added to the list based on referrals provided by the initial set of interviewees.
i. Patient Advocacy Groups (PAG): The main class of stakeholders that represents a multitude of patients living with rare diseases spread across India. They are the voices representing their rare disease community and are key players in the rare disease scene in the country. As such, PAGs are reliable sources of information for current state assessment, and provide valuable insights.
ii. Independent Patients and Disability Advocates: Although less in number, there are also various individuals who are patients and advocates for rare diseases and disabilities and often not fully associated with a specific organization. They provide valuable inputs from the patient’s perspective.
iii. Physicians: The main interface between the patients and medical advancements in diagnosis and treatments. They are a key stakeholder in the rare disease landscape in a country like India where people from rural and lower socio-economic or educational backgrounds depend heavily on advice from their doctors.
iv. Policy Professionals: India’s rare disease policies are still evolving and personnel working at the frontline in this endeavor are good sources of information for current state assessment and can also provide inputs on implementation strategies.
v. Industry: This class of stakeholders includes Biopharma sponsors, Service Providers, Diagnostic Labs, and Contract Research Organizations (CRO). India has seen a growth in industry targeting the rare disease community, with the formation of a number of organizations that provide services or products for rare disease patients. These range from smaller startups as well as bigger companies with wider reach across the country and internationally. The successful functioning of these organizations depends on the availability of proper infrastructure and policies regarding rare diseases, and are hence important stakeholders in these discussions. While CROs do not specifically focus on rare diseases, they are the main drivers of clinical trials in the country and can thus provide valuable inputs for current state assessment.
3. Design of Interview questionnaires: Initial interview questionnaires were drafted for (i) Patients and PAGs, and (ii) Healthcare practitioners, Industry, and Researchers. Sample questionnaires are included in Annexures II and III
4. Interviews and Post interview follow ups: Candidate interviewees were sent email invites which provided a brief introduction of a patient-owned rare disease registry project and requesting participation in a no-obligation discovery interview.
Interviews were scheduled as per the candidate’s convenience and were conducted via web-based audio or video calls such as Zoom, Google Meet or WhatsApp. Zoom was the preferred mode for most interviews. Zoom interview sessions were recorded with consent/permission.
All interviewees were sent follow up emails, thanking them for their participation and requesting introductions to possible interviewees in their network. Interviewees were also emailed to clarify any existing information and follow up with additional questions.
5. Analysis of Data: All interviews were recorded with permission, and transcribed into word documents. All answers were coded and then analyzed. A key highlights table was generated which captures aspects relevant to the main themes being analyzed.
A total of 102 individual email requests were sent to candidate interviewees. As of 28 December 2020, 28 candidates had accepted, 2 declined to participate in the study, and the remaining ones are yet to respond. We have made attempts to follow-up with non-responders, and those who had postponed interviews after acceptance, mindful of their privacy rights, after a month has elapsed.
i. Health ID: Every Indian will get a Health ID that will be used to uniquely identify and authenticate the individual, and allows for sharing of their health records across multiple systems and stakeholders with their informed consent.
ii. Digi Doctor: The program aims to create a single repository of all doctors enrolled in nation which includes all their relevant details such as name, qualifications, specializations, registration number with State medical councils, years of experience, etc. would be an essential building block of the digital health infrastructure of the country. The registry is to be updated as doctors gain experience and expand skill sets.
iii. Health Facility Registry (HFR): The NDHM also calls for the creation of a single repository of all health facilities in the country, which is centrally maintained, and allows exchange of information from public and private health care facilities across the country, provide a secure common platform to the facilities to maintain all essential information. Facilities should be able to update their profiles periodically.
iv. Electronic Medical Records (EMR): will contain a digital version of a patient’s medical and treatment data from a single health facility.
v. Personal Health Records (PHR): is an app that electronically stores all health related information of the individual, in a manner that conforms with national interoperability standards. While the record can be built on information from multiple sources, full control regarding managing records rests with the patient. This can be integrated with other facilities such as telemedicine, e-pharmacy, and also used for creating a national health registry.Key features of the NDHM include the following20:
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FEASIBILITY OF RARE-X INDIA PILOT – INTERVIEWS WITH STAKEHOLDER
IndoUSrare conducted a study to understand the rare disease landscape in the country with specific focus on patient data collection and sharing and patient registries. Interviews were conducted with different stakeholders to understand their interest in participation in a patient-owned health data registry and the feasibility and roadblocks for a platform that supports global sharing of patient owned health information.
Details of stakeholder mapping, and interview design have been provided in the Methodology section.
Thirty-two interviews were conducted. Annexure IV provides details of the interviewees and the organizations they represent. Four candidates postponed scheduled interviewees. All calls were recorded, and transcribed. Answers were coded and analyzed.
All interviewees were sent follow up emails, thanking them for participation and requesting contact information for possible interviewees in their network. This resulted in around 50 leads (PAGs, researchers, physicians, and government officials), some overlapping with the existing list of candidate interviewees.
The key themes that came out of the interviews have been described in the following sections.
Key Themes from Interviews
1. Ownership of a patient’s health information
When asked who they felt should be the owner of a patient’s health information, 63 % of the interviewees were of the opinion that patients should be the owners of their own health information. These comprised all the types of stakeholders such as representatives of industry, patient advocates, physicians, as well as policy professionals. Among these, 5 felt that the Government and its institutions should be the custodian, while three interviewees felt that clinicians should be the custodian. Four interviewees (<15%) of stakeholders felt that the clinicians should be the owner of a patient’s health information. This too came from interviewees of different backgrounds. Two interviewees considered the government to be the rightful owners to the patient’s health information; one is a patient advocate, and the other a rare disease service provider. Two interviewees chose not to answer. Interviewees who did not feel the patient should be the owner justified their answer stating that in India, a vast majority of people especially those with a rural and less educated background, do not have the knowledge to be able to take health related decisions themselves and rely on their clinicians.
2. Awareness in general public regarding newer technologies such as NGS
Overall, the awareness in the general public was considered very poor. However, this has seen an improvement in recent years due to efforts of various groups as well as marketing campaigns from private diagnostic companies. Even though people are aware of the existing technology, it is often beyond their reach financially, which is a hindrance to these techniques being used widely. Additionally, there is a very small pool of specialists who can analyze and interpret the data fruitfully, which results in misinterpretation as well as sub optimal use of expensive tests.
3. Assessment of existing patient registries in the country
All the interviewees were of the opinion that India does not have good quality patient registries of national remit. Many of the hospitals, PAGs and individual research institutions may have their own database, but these are disparate and inaccessible. Many interviewees expressed hope in the Rare disease registry launched by ICMR. However, this registry is still not functional 3 years after launch, and does not cover all diseases.
There have been few initiatives from various groups to fill this gap and a few pan India registries do exist. These include the Rare Disease Registry of India (RRDI) set up at the JK Lone SMS Hospital, Jaipur, the Birth Defects Registry of India (BDRI), and registries set up at national level institutes such as SGPGI, Lucknow, AIIMS- New Delhi, and CMC Vellore.
4. Interest in participation in a patient-owned health data registry pilot
All interviewees expressed interest in a patient-owned rare disease registry initiative, and 30 showed interest in participation when a pilot is launched in the country. The two interviewees who declined to participate cited retirement and other personal issues as a reason. However, even among those who showed interest, a few qualified their answer by adding that as representatives of larger organizations, they require consent from member patients or institutional approval as applicable. Yet a few others felt the need for more information on the initiative and what was expected from their side before committing.
5. Key Concerns for implementation of a patient-owned health data registry in India
The following emerged as key concerns regarding implementation of a patient-owned rare disease registry in India:
a. Data security and confidentiality: Even when interviewees were reasonably convinced of the value of sharing data and maintaining registries to further research and drug discovery as well as to ensure representation in clinical trials, there were general concerns regarding data security. Specific questions asked were related to how data confidentiality would be ensured and how patient’s privacy would be protected.
b. Inhibition from Patients: Indian society has a significant level of stigma associated with rare diseases and the phenotypic manifestations of many diseases, which stem from deep rooted cultural traditions and prevalent superstitions, as well as due to lack of awareness in the general public. This can result in an inhibition from the patient towards reporting or sharing data related to rare diseases.
c. Challenges in Implementation: Another key concern was regarding the implementation of the project in the country. The interviewees felt that implementation of a project would have to overcome the myriad of bureaucratic and infrastructure related hurdles in the country.
d. Cost to patient: Interviewees, especially patient representatives, were worried about the cost to the patient including that of the medical tests that would be required as raw data.
e. Logistics for data collection: Questions were raised regarding the project implementation pipeline – will there be Central and State government involvement, what are the infrastructure requirements of the project, will the Indian medical system support the implementation of the project?
f. Other concerns: Other concerns raised included those regarding the legal, regulatory and jurisdiction aspects of data collection and global sharing, lack of time to enter large volumes of data.
6. Suggestions for implementation of a patient-owned health data registry in India
The main suggestions offered for the successful implementation of a patient-owned rare disease registry pilot in the country were as follows:
a. The consensus was that collaborations between and concerted action from all stakeholders is necessary for the successful implementation of a patient-owned rare disease registry project in India.
b. While many interviewees believed that government involvement is needed to achieve maximum reach for a patient-owned health data registry project, because a major chunk of the population in India still depends on state run health schemes and insurance is largely unavailable. At the same time, however, they suggested that it is preferable to work through the non-government sector for better performance due to bureaucracy in government.
c. Many interviewees stressed the importance of including Awareness or Education campaigns for patients and clinicians during the implementation phase, as lack of awareness is a key issue for rare diseases in India. Such campaigns would help them understand the benefits of a patient-owned health data registry program and the value of data sharing and registries in general.
d. Many interviewees felt it would be useful to include elements that would provide immediate or sustained benefits to the patient, such as the inclusion of resources for networking, and information. Such an initiative would help to attract people to use the platform and ensure continued use.
e. Clinicians interviewed felt that minimizing paperwork would help improve the entry of information as having numerous forms to fill and a multitude of data elements would discourage use of the platform.
f. Lack of time was one of the key concerns raised by clinicians, who felt that help with manpower for data collection and entry would be an encouraging step towards use of the platform.
g. One clinician interviewed suggested the inclusion of imaging data in the EHR data collection to improve the usability of data and allow for review at a later point of time.
h. One interviewee suggested the use of a multi-level structured approach to data collection to ensure maximum coverage. This would ensure that while detailed medical history is welcomed and encouraged, anyone with a minimal set of health information can access and add data.
EDUCATION AND OUTREACH FOR PATIENTS
Given that the patient registries are almost non- existent and there is a significant lack of understanding of the need for and methods of collecting high quality data, there is a need for concerted efforts towards education and outreach for patient advocacy groups with a focus on the importance of data quality, privacy, and processes.
Webinars are a key information dissemination and educational platform. The authors recommend webinars to disseminate knowledge about the importance of data quality, privacy and the methods to achieve these goals.
CONCLUSIONS AND RECOMMENDATIONS
The figure below summarizes our findings of the feasibility analysis conducted during July – December 2020, and lists out the different elements to be considered moving forward.
1. SWOT Analysis
2. Recommended Future Plans for a patient-owned health data registry in India
Based on our analysis, IndoUSrare recommends the introduction of a patient-owned health data registry, like RARE-X, in India in a phased manner. Even though India currently has various roadblocks as listed above for full-fledged implementation of a patient-owned registry allowing global data sharing, overall, India has been conducive to moving towards digitization, as evidenced by nationwide acceptance of digital payments in a fairly short period of time. Furthermore, the authors recommend leveraging the growing trend of digitizing healthcare and increasing awareness around data privacy and protection, and the individual’s rights to ownership of their own personal data.
I – The IndoUSrare Project Team
This study is conducted by IndoUSrare. The following team members are included in planning, analysis, execution, and preparation of deliverables