Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation. Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.

1. Welcome
Clinical Data Security and Integrity
Name: Rohit Kulkarni
Qualification: M.Pharmacy
Student ID :017
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2. Index
❖ What is Clinical Data
❖ Importance of Security And Integrity
❖ Regulatory Compliance
❖ Technologies
❖ Case Studies
❖ Future Trends
❖ Conclusion
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3. What is Clinical Data
Clinical data refers to data collected during the
course of providing healthcare to the patients
includes wide range of data such as medical
history, laboratory test results, vital signs and
other this data serves as a crucial resources for
the health care providers for monitoring patient
progress.
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4. Importance Of Security
Importance of security in clinical trails can
be defined as critical measures and
protocols implemented to safeguard various
aspects of trail.
❑ Data protection
❑ Participant safety
❑ Data breaches
❑ Unauthorized access
❑ Regulatory compliance
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5. Strategies to data security
❑ Establish robust access control to
limit access based on roles and
permissions.
❑ Raising awareness among employees
among security attacks like
phising,malware.
❑ Conducting regular audits for
ensuring the safety of the data,
❑ Installing antivirus software and
regularly updating them.
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6. Importance Of Integrity
❑ Data integrity is a degree to which collection of data is
complete ,consistent and accurate throughout its life
cycle.
❑ The importance of integrity in clinical trails refers to
honesty and transparency throughout the trail
❑ It involves adhering to scientific methodology avoiding
bias and conflict of interest.
❑ Integrity is essential for building trust among
stakeholders, healthcare providers, including
participants and public.
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7. Strategies to data integrity
❑ Establishing standard procedures for data
collecting, data storage .
❑ Implement data validation checks to ensure that
the data entered meets certain criteria and rules.
❑ Ensuring the data is entered correctly without any
errors,double checking the enteries,using the
spell-check tools for maintaining the accuracy.
❑ Creating a checklist to ensure that all the data is
entered properly without missing.
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8. Regulatory Compliance
❑ Regulatory compliance refers to adhering to
the law,regulations,guidelines set by the
regulatory bodies to ensure safety,integrity
and confidentiality of the subject
➢ Intuitional review board.
➢ Good clinical Practice
➢ Good documentation practice
➢ Informed consent
➢ Safety reporting
❑ Failure to comply to the regulatory compliance
can lead to serious failure of the
trails,suspension,fines.
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9. Technologies
❑ Technology plays a major role in advancing
medical research and improving patient
outcomes
❑ Some of the technologies used in clinical
research are:
➢ Electronic data capture.
➢ Electronic health records
➢ Remote patient monitoring .
➢ Telemedicine platforms.
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10. Case Studies
❑ Anthem data breach(2015): Anthem one of the
largest health insurance company in united states
experienced a data breach in 2015. hackers gained an
unauthorized access to the database compromising
personal information of approx. 75.8 millions individuals
including date of birth, address.
❑ Singapore health system data breach(2018):
Singapore government health system suffered a
large data breach personal information about
1.5millions including the prime minister was
compromised this highlighted the vulnerabilities
data infrastructure and led to a review of
cybersecurity measures in Singapore health system.
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11. Future Trends
❑ Decentralized trails
❑ Artificial intelligence
❑ Machine learning
❑ Real world evidence
❑ Block chain technology
❑ Regulatory innovations
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12. ❑ Collabration:collabration is essential for the
conduct of clinical trails like:
➢ Collabration with stake holders,researchers,health
care providers, participants,regulatory bodies .
❑ Education: By taking a initiatives like conducting:
➢ Training programs,certification,workshops
➢ Providing indivuals with necessary skills and
knowledge
❑ With the help of education and collaboration
organization can strengthen their defense against
data breaches, unauthorized access
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Collabration And Education

13. Conclusion
❑ Clinical data security and integrity are one of the most
important aspects of modern healthcare
❑ prioritizing security measure and upholding ethical
standards.
❑ Collabration and education are important for promoting
confidentiality, accuracy.
❑ As we are advancing towards digital healthcare it is
important to keep an eye on emerging security threats
and implement proactive measure to tackle them.
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14. Referencees
❑ https://osf.io/e3y2f/download
❑ https://www.cdc.gov/nchhstp/funding/announcements/ps18-
1801/ppt/AttachmentB_SecurityConfidentialityTraining.pptx
❑ https://www.transceleratebiopharmainc.com/rbminteractiveguide
/best-practices-for-implementation/data-
integrity/#:~:text=According%20to%20the%20World%20Health,acc
urate%20throughout%20the%20data%20lifecycle.
❑ https://riskxchange.co/1006895/what-is-integrity-in-cyber-
security/
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15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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