“We are excited to announce that Klinisol has successfully completed a System and Organization Controls (SOC) 2 Type II audit, performed by Sensiba San Filippo, LLP (SSF). Developed by the American Institute of Certified Public Accountants (AICPA), the SOC 2 information security standard is an audit report on the examination of controls relevant to the trust services criteria categories covering security, availability, processing integrity, confidentiality and privacy. A SOC 2 Type II report describes a service organization’s systems and whether the design of specified controls meets the relevant trust services categories, and assesses the effectiveness of those controls over a specified period of time. Klinisol’s SOC 2 Type II report did not have any noted exceptions and therefore was issued with a “clean” audit opinion from SSF.”
Author: admin
Klinisol providing support for Montefiore Medical Center
KLINISOL, is excited to announce that we engaged in a contractual relationship with Montefiore Health System, providing support with access to the KLINISOL‘s Platform and Services for the Department of Cardiology Research.
KLINISOL eConsent application is a patient centric solution that supports clinical research entities increase patient recruitment and retention by reducing the cost, time, and effort through employment of regulatory compliant virtual communication. The informed consenting process performed with the KLINISOL eConsent application, ensures verifying identification of the patient or the LARs, comprehension, and obtains appropriate documentation.
KLINISOL eConsent, is a HIPAA and 21 CFR Part 11 FDA compliant application.
This is a significant and crucial contract award for KLINISOL, and it further establishes KLINISOL as an industry leader in the clinical research field. It reaffirms our belief that our business model can take advantage of the current industry downturn by capitalizing on a gap in the market allowing companies like KLINISOL to thrive by offering a cost effective alternative to larger organisations in the same business line.
A very special thank you goes out to Mario Garcia, Azeem Latib and Nadia Persaud of the Montefiore Health System Cardiology Department and Structural Heart Team whose genuine support and tireless feedback made this project happen.
Klinisol engaged the services of Sensiba San Filippo LLP
KLINISOL has engaged the services of a renown independent auditor, Sensiba San Filippo LLP, with 40 years of experience, who will execute a SOC 2 Type II attestation engagement on the AICPA’s Trust Services Criteria, Security (Common Criteria), Availability and Confidentiality categories. A pre-audit readiness phase will also be included as part of the overall engagement. KLINISOL will use the Vanta readiness platform, to complete the pre-audit steps. The anticipated testing period for the SOC 2, Type II is expected to conclude after a 3-month observation period.
Sensiba San Filippo LLP will examine KLINISOL system description based on the criteria for a description of a service organization’s system in DC section 200, 2018 Description Criteria for a Description of a Service Organization’s System in a SOC 2 Report, and the suitability of the design and operating effectiveness of controls to meet the criteria for the relevant SOC 2 categories set forth in the AICPA Trust Services Criteria for Security, Availability, Processing Integrity, Confidentiality, and Privacy.
Thank you Sensiba San Filippo LLP, for bringing your experience on board to support KLINISOL standardized service provision. KLINISOL is looking forward to working with you!
Klinisol undergoing SOC 2 audit through VANTA
As part of our efforts to maintain regulatory compliance and standardization requirements, on December 30, 2020, KLINISOL started leveraging the Vanta software to actively work towards and achieve the SOC 2 certification.
SOC 2 is a compliance requirement, that stands for Service and Organization Controls, that tech companies should meet today in order to be competitive in the market.
Vanta is a SOC 2 readiness software solution that uses read-only APIs and other custom-built ancillary tools to continuously monitor whether a company is adhering to a standard set of common SOC 2 controls.
Klinisol has also engaged with an AICPA-accredited auditor who will file our SOC 2 report outside of the Vanta platform.
Klinisol Achieves HIPAA Compliance with Compliancy Group
Klinisol has demonstrated its good faith effort toward HIPAA compliance by completing Compliancy Group’s proprietary HIPAA compliance process.
Press Release:
Klinisol is pleased to announce that it has taken all necessary steps to prove its good faith effort to achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA). Through the use of Compliancy Group’s proprietary HIPAA solution, The GuardTM Klinisol can track their compliance program and has earned their Seal of ComplianceTM. The Seal of Compliance is issued to organizations that have implemented an effective HIPAA compliance program through the use of The Guard.
HIPAA is made up of a set of regulatory standards governing the security, privacy, and integrity of sensitive healthcare data called protected health information (PHI). PHI is any individually identifiable healthcare-related information. If vendors who service healthcare clients come into contact with PHI in any way, those vendors must be HIPAA compliant.
Klinisol has completed Compliancy Group’s Implementation Program, adhering to the necessary regulatory standards outlined in the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, Omnibus Rule, and HITECH. Compliancy Group has verified Klinisol good faith effort to achieve HIPAA compliance through The Guard.
“Research through Ai”
Clients and patients are becoming more aware of HIPAA compliance requirements and how the regulation protects their personal information. Forward-thinking providers like KLINISOL choose the Seal of Compliance to differentiate their services.
About KLINISOL
Klinisol is the leading remote clinical trial solution created by research coordinators in cooperation with sponsors, PIs and SUB-PIs to assist clinical research entities overcome the constraints brought about by COVID19.
About Compliancy Group:
HIPAA should be simple. That’s why Compliancy Group is the only HIPAA software with expert Compliance CoachesTM holding your hand to simplify compliance. Built by auditors, Compliancy Group gives you confidence in your compliance plan to reduce risk, increase patient loyalty, and profitability of your organization. Visit https://www.compliancy-group.com or call 855.854.4722 to learn how simple compliance can be.