We are healthcare’s trusted partner for comprehensive regulatory and  compliance advisory services. We help your business minimize risk and stay profitably compliant.

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Compliance and regulations consulting

We provide advisory and solutions to the ever-increasing demands of compliance across the various facets of hospital and healthcare technology verticals. A large number of hospital licenses, permits, approvals and other legal documents are required to meet regulatory demands and protocols set up by the government and other regulatory bodies. Moreover, these regulations and compliances are constantly changing, and hence need to be reviewed and updated by the hospital’s or organization’s management, on a periodic basis.  Accreditation by the country’s healthcare regulatory body and other globally renowned regulatory bodies goes a long way in communicating a high level of healthcare quality being provided in a particular facility.

Our specialist teams of highly experienced business consultants, lawyers, legal advisors and operational experts assist clients in acquiring and maintaining the required hospital licenses and meet the regulatory requirements and approvals, thus allowing them to stay “profitably compliant.”

Compliance and regulations consulting
Practice areas and verticals

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Compliance consulting for new hospitals

Hospital projects are complex, highly regulated and controlled, making compliance a crucial factor to ensure success. Compliances and regulations for a hospital project encompass aspects related to land, building, medical equipment, fire safety, patient safety, insurance, quality, telemedicine, data security and others. The complex nature of these requirements is responsible for many projects being stalled midway and resulting in colossal waste of money and time.

Camomile Healthcare works with investors and entrepreneurs to plan compliant facilities and helps in obtaining the required approvals and licenses at the right time.

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Digital health and medical technology compliances

Camomile Healthcare assists organizations developing or operating digital healthcare services / products that use technology, new processes, artificial intelligence (AI), machine learning and other tools to cater to the healthcare industry. 

Our services cover the following,

  • Regulations and compliances related to SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device)
  • General obligations of manufacturers / service providers, such as risk management, clinical performance evaluation, technical documentation and others
  • Information supplied with the device / service, such as labelling and usage instructions
  • Accreditation requirements
  • Patient safety and confidentiality
  • Information use and privacy

 

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Hospital operational compliances

Every day, healthcare service providers and administrators confront the daunting task of complying with a growing number of regulations. These regulations are largely intended to ensure that patients receive safe, high-quality care. The number of manhours spent to comply with the regulatory requirements is huge and includes time of the doctors, nurses and administrators.

We provide services that enable compliances of healthcare services delivery in the following areas,

  • Data privacy
  • Patient confidentiality
  • Equipment and radiation related
  • Doctors and nurses
  • Medico legal
  • Organ related
  • Others

 

Camomile Healthcare tracks your compliance requirements in real-time and advises on the necessary steps to be taken by the hospital.

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