Dataset Information

Before and after enforcement of GDPR: Personal data protection requests received by Croatian Personal Data Protection Agency from academic and research institutions.

ABSTRACT: Introduction:The European Union's (EU) General Data Protection Regulation (GDPR) was put in force on 25th May 2018. It is not known how many personal data protection requests the national authority in Croatia had received before and after GDPR, and how many of those were related to research. Materials and methods:We obtained data from the Croatian Personal Data Protection Agency (CPDPA) about requests/complaints related to personal data protection that were received specifically from academic/research institutions, specifically the number and type of all cases/requests between the years 2015-2019. Results:In 2018, CPDPA had a dramatic increase in the number of requests in the post-GDPR period, compared to the pre-GDPR period of the same year. In 2019, CPDPA received 2718 requests/complaints; less than in the year 2018. From 2015 to 2019, CPDPA received only 37 requests related to research. Conclusions:Very few requests about personal data protection from academic and research institutions in Croatia were submitted to the national Croatian data protection authority. Future studies could explore whether researchers have sufficient awareness and knowledge about personal data protection related to research, to adequately implement the GDPR regulations.

SUBMITTER: Puljak L

PROVIDER: S-EPMC7394253 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Before and after enforcement of GDPR: Personal data protection requests received by Croatian Personal Data Protection Agency from academic and research institutions.

Puljak Livia L Mladinić Anamarija A Iphofen Ron R Koporc Zvonimir Z

Biochemia medica 20200805 3

<h4>Introduction</h4>The European Union's (EU) General Data Protection Regulation (GDPR) was put in force on 25th May 2018. It is not known how many personal data protection requests the national authority in Croatia had received before and after GDPR, and how many of those were related to research.<h4>Materials and methods</h4>We obtained data from the Croatian Personal Data Protection Agency (CPDPA) about requests/complaints related to personal data protection that were received specifically f ...[more]

PMID: 32774116

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Project description:BackgroundIn 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients.MethodsThe authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively.ResultsThe sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days.ConclusionsAmong patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

Project description:As of May 2018, all relevant institutions within member countries of the European Economic Area are required to comply with the European General Data Protection Regulation (GDPR) or face significant fines. This regulation has also had a notable effect on the European Union (EU) candidate countries, which are undergoing the process of harmonizing their legislature with the EU as part of the accession process. The Republic of Serbia is an example of such a candidate country, and its 2018 Personal Data Protection Act mirrors the majority of provisions in the GDPR. This paper presents the impact of the GDPR on health data management and Serbia's capability to conduct international health data research projects. Data protection incidents reported in Serbia are explored to identify common underlying causes using a novel taxonomy of contributing factors across aspects and health system levels. The GDPR has an extraterritorial application for the non-EU data controllers who process the data of EU citizens and residents, which mainly affects private practices used by medical tourists from the EU, public health care institutions frequented by foreigners, as well as expatriates, dual citizens, tourists, and other visitors. Serbia generally does not have well-established procedures to support international research collaborations around its health data. For smaller projects, contractual arrangements can be made with health data providers and their ethics committees. Even then, organizations that have not previously participated in similar ventures may require approval or support from health authorities. Extensive studies that involve multisite data typically require the support of central health system institutions and relevant research data aggregators or electronic health record vendors. The lack of a framework for preparation, anonymization, and assurance of privacy preservation forces researchers to rely heavily on local expertise and support. Given the current limitation and potential issues with the legislation, it remains to be seen whether the move toward the GDPR will be beneficial for the Serbian health system, medical research, protection of personal data and privacy rights, and research capacity. Although significant progress has been made so far, a strategic approach is needed at the national level to address insufficient resources in the area of data protection and develop the personal data protection environment further. This will also require a targeted educational effort among health workers and decision makers, aiming to improve awareness and develop skills and knowledge necessary for the workforce.

Dataset Information

Before and after enforcement of GDPR: Personal data protection requests received by Croatian Personal Data Protection Agency from academic and research institutions.

Publications

Before and after enforcement of GDPR: Personal data protection requests received by Croatian Personal Data Protection Agency from academic and research institutions.

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