GENERAL DATA PROTECTION REGULATIONS

 GENERAL DATA PROTECTION REGULATIONS

INTRODUCTION :- In European countries general data protection regulation came into action in 2018.The personal information of the European subjects should be secured according to the GDPR and also adherence to the HIPAA and HITECH.GDPR explains the data rights of European subjects and non – fulfillment of GDPR will offense a penality.

SALIENT FEATURES OF GDP

1) The important aspects to be protected of European people include like locality,genetic information,IP number,biometric and e-mail.

2) The rules and regulations also implies to the companies outdoor to the EU as they resides within EU.

3) The language used in the ICF should be understandable by human subjects.

4) It explains the risk-benefit analysis and work of data protection officers.

1)DATA PROTECTION OFFICER (DPO) :-

a. Data controllers :- They regulate the motive for what cause the data is processed and by whom.

b. Data processors :- The qualified person processes the personal data in the name of data controller.

2)COMPLIANCE :-

 GDPR complance include like the consent provided to subjects in a easy approachable form.Enahced provincial liberty.

3)DATA BREACHES :-

 In the event personal data breach,that data controller should intimate to the higher authority within 72 hours.

4)PERSONAL DATA :-

The personal data include the information which is used to identifiy the subject.

 There are mainly three rights of subjects data sovereighty.

1)Equitable to approach :- Human subjects has equitable right to approach the data controller to know the personal data handling process.Upon request by the subject a copy of data processed should be provided without charge.

2)Deletion :- Upon request by the subject the data should be deleted.The privacy choice should be made available by the data controllers to the subjects through non-payment institutional rules.

3)Transmissibility :- capability of the subject to collect the data from one data controller to another.

CONCLUSION

GDPR is a safe-keeping law of personal data of the EU people.GDPR compliance need companies that control and process the personal data of EU people and should engage a data protection officer(DPO).

REFERENCES

1) https://www.socra.org/blog/an-overview-of-the-general-data-protection-regulation-gdpr-for-clinical-research-organizations/

2) https://www.advarra.com/blog/the-gdpr-and-its-impact-on-the-clinical-research-community-including-non-eu-researchers/

3) https://www.pharm-olam.com/blog/gdpr-clinical-trial-tips-for-non-eu-based-sponsors

SIDDAM SRAVANI(B.Pharm)

Clinosol ID :- 019/0121.