Regulatory and hospital compliance consulting for an innovative healthcare delivery model

We worked with a Fortune 100 company to improve hospital compliance while navigating India’s complex legal and regulatory framework with respect to healthcare.

We created a patient centric compliance plan with a comprehensive approach addressing infrastructure, clinical workflow, supply chain and telemedicine that met NABH and JCI standards.

The client was a US$100 billion Indian conglomerate venturing into healthcare.

Their aim was to provide patient centric care across primary, secondary and tertiary care formats by maximizing deployment of digital health tools and improving remote care delivery.

Camomile’s role was to study the healthcare model and provide advice on how it could be compliant with existing healthcare regulations and standards in India.

Camomile’s healthcare consultants, with expertise in obtaining and maintaining hospital licenses across building infrastructure, medical equipment and digital health, were deployed on this assignment.

The workflows proposed by the client were a combination of physical and digital modes of healthcare delivery. It also empowered a new cadre of personnel to conduct functions earlier performed by doctors and nurses.

Camomile mapped the proposed healthcare delivery model into an omnichannel patient journey and confirmed that it was compliant to operate under current regulations.

Legal and regulatory risks imminent in operating the delivery model were analyzed for the following

1. Building infrastructure
2. Clinical workflows – transfer of clinical responsibilities across various clinical personnel & various clinical settings
3. Digital health and latest telemedicine practice guidelines released in March 2020 by the Ministry of Health and Family Welfare
4. Medical equipment procurement, installation and operations
5. Remote care delivery
6. Insurance reimbursement and new plan approvals
7. Operational compliance to NABH and JCI standards and others

Interdependencies and documentation required by different bodies to obtain and retain every license were analyzed.

Camomile assisted in making the client’s requirement of patient centric compliant care a reality.

• Camomile generated a comprehensive checklist of hospital infrastructure licenses required for the launch and continued operations
• Telemedicine practice guidelines required to be complied with across areas of data privacy, telecom, mobile communications, operational guidelines were provided
• IRDA regulations, time and effort required for approval of specific insurance plans for the proposed services were detailed
• Camomile helped the client understand regulations around operating remote healthcare delivery models like mobile medical units
• NABH and NABL compliance requirements, space standards, operational standards and key metrics to be tracked relevant to the suggested healthcare delivery models were suggested
• Compliance team required to execute, including job responsibilities, qualifications and efforts required at every stage of the project was planned and provided as a clear outcome-oriented implementation plan
• RegTech software to track, monitor and ensure compliance throughout the life cycle was suggested