Privacy, security, reliability of Digital data of human samples along with ethical standards are of high concern for the consumer and regulatory authorities. We at PatientMD vouch for maintaining high standards of the procedure and data security.
We believe in following best practices procedures that are expressed and laid out by eminent scientific societies or regulatory bodies to maximize error free processes and strict compliance to quality standards.
Organizations operating in the healthcare industry are striving to curb the pressure to use resources as efficiently and dynamically as possible. They must provide innovation in advance analytics in patient care products and services enabled and do so while maintaining compliance with an increasing stress of privacy and security regulations. We at PatientMD understand the requirement of confidentiality and security of personal genetic data and how sensitive that information can be for the individual. As a global entity, we are compliant with the Health Insurance Portability and Accountability Act (HIPAA) , 2019 and amendments thereof constituted by United States of America to help ensure that their patient data is kept confidential and secure as per legal requirement.
The genetic sequencing technology is a rapidly developing science requiring high level of expertise and procedural setups. Our sequencing lab is Sap enabled genomics facility and ISO 9001: 2015 compliant ensuring high level of integrity and standard of Wet laboratory technique.
The Bioinformatics based analysis of the next generation based sequencing data for detection of clinically important variants of the patient sample follow the path of guidelines laid out competent authorities and Institutes Like GATK best practices guidelines by Broad Institute.
The saliva collection kit used for obtaining the DNA sample is Oragene DX kit, approved by FDA, USA is one of the best in the world for ensuring stability of the Molecule and ensuring personal safety and quality.
Our procedures are practices are also compliant with Clinical Laboratory Improvement Amendments (CLIA ) of 1988 of United States federal regulatory standards to ensure accuracy, reliability and timeliness of test results of human samples.