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How will the upcoming GDP regulations impact healthcare and patient safety? Which companies will be affected and how can we go about implementing it? Technology is progressing with time, and adaptation is vital. Data is increasingly valuable for any competitive, modern-day company – especially in healthcare, where real world data is making such a huge difference. Data protection is becoming a real hot topic because of an increasing reliance on big data. Sensing this, several developed countries have come up with certain rules and regulations to protect confidential data. Data protection is the process of protecting data by linking the collection and dissemination of data and technology. It strikes a balance between individual privacy rights while allowing data to be used for business purposes. Data protection is also called data or information privacy. All forms of data should be protected, whether personal or corporate. Data protection not only deals with data protection, but also integrity, corruption, and privacy. Data privacy is not highly regulated in countries like the United States. So, there is a serious need to implement new laws to protect data. This blog post is an attempt to explain how the General Data Protection Regulation (GDPR) is a good choice for corporates using big data analytics for business decisions, especially for pharma analytic firms who maintain and protect vital and confidential client data. The General Data Protection Regulation, approved in the EU, is a must follow for all the EU nations. It applies directly in all the EU Member States from 25th May, 2018. The GDPR rules apply to all the private sector organizations in the EU or organizations outside the EU which target the EU residents. Businesses must protect the personal data and privacy of the EU citizens for transactions within the EU member states as per the GDPR mandates. The GDPR also regulates the export of personal data outside the EU. The provisions are consistent across all the 28 EU member states. So, companies have just one standard to meet within the EU. However, the standard is quite high, and most companies will have to make a large investment to meet and administer it. The general objectives of the GDPR are to: – Protect personal data (including data relating to patient care), its processing, and rules related to the free movement of personal data – Protect the fundamental rights and freedoms related to personal data, in particular the right to the protection of personal data – The free movement of personal data within the European Union can be neither restricted nor prohibited because of the norms connected with its protection and the processing of personal data All the companies that store or process personal information about the EU citizens within the EU states must comply with the GDPR, even if they do not have a business presence within the EU. The companies which must comply are businesses that have: – A presence in an EU country – No presence in the EU, but process personal data of the European residents – More than 250 employees – Fewer than 250 employees, but its data processing affects the rights and freedoms of data subjects, is not occasional, or includes certain types of sensitive personal data. – This effectively means almost all companies are impacted by the GDPR. The GDPR outlines diverse roles for compliance: the Data Controller, Data Processor, and the Data Protection Officer (DPO). The data controller defines how personal data is processed and the purposes for which it is processed. The controller is also responsible for ensuring that outside contractors comply. The data processors are the internal groups who maintain and process personal data records, or any outsourcing firm that performs all or part of these activities. The processors are liable for breaches or non-compliance. Thus, both your company and the processing partner, such as a cloud provider, will be liable for penalties, even if the fault is entirely with the processing partner. The GDPR requires the controller and the processor to designate a DPO to oversee the data security strategy and GDPR compliance. A DPO is relevant if companies process or store large amounts of the EU citizen data, process or store special personal data, regularly monitor data subjects, or are a public authority. Some public entities, like law enforcement agencies, are exempt from the DPO requirements. The GDP protects data including: – Identity information such as name, address, and ID numbers – Location, IP address, cookie data, and RFID tags – Health and genetics – Biometrics – Racial or ethnic data – Political opinions – Sexual orientation The GDPR will have a significant impact on healthcare, patient data, and patient safety. Although the regulations might put added pressure on nurses and doctors, who require fast and easy access to patient data, patients will be left pleased that their data is being treated with the highest levels of confidentiality at all times. Some healthcare providers, particularly those who deal with rare disease patient groups and are therefore heavily reliant on carefully procured data from a specific community, are worried. However, it should be noted that data protection law is not applicable to data that is rendered anonymous to such an extent that the patient is no longer identifiable. This means that the data in question can be used without restriction and the data can still be helpful when it comes to understanding a rare disease. To adapt, healthcare organizations will need to simplify and optimize clinical workflows to enable the fast and secure access to patient information. 1) Create a sense of urgency that comes from the top management — The executive leadership must prioritize cyber preparedness. Compliance with global data hygiene standards is a part of this preparedness. 2) Involve all the stakeholders — IT alone is ill-prepared to meet the GDPR requirements. There must be a task force that includes marketing, finance, sales, and operations — any group within the organization that collects, analyzes, or uses customer data. A task force can better share information useful to those implementing the technical and procedural changes, and they will be better equipped to deal with any impact on their teams. 3) Hire or appoint a DPO — The GDPR does not imply whether the DPO has to be a discrete position. So, a company can name someone in a similar role as long as that person can ensure the protection of data with no conflict of interest. Or, a DPO must be hired. A DPO might not be needed full time. A virtual DPO is an option here. The GDPR rules allow a DPO to work for multiple organizations. So, a virtual DPO would be a consultant who works as needed. 4) Create a data protection plan — Most companies already have a plan in place. Yet, they must review and update it to ensure that it aligns with the GDPR requirements. As a company dedicated to simplifying healthcare market access complexities, phamax can help you with patient-level data analytics, budget impact modeling, and regulatory landscape assessment. Our friendly, expert team is always here to answer your questions. Get in touch today.
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Službenik za zaštitu osobnih podataka Službenik za zaštitu osobnih podataka (DPO - Data Protection Officer) mora imati holistički pogled na ukupno poslovanje i biti neovisan od voditelja obrade. Glavni zadatak mu je da potpuno neovisno omogući primjenu odredbi Uredbe u organizaciji/društvu/tijelu javne vlasti. Službenik za zaštitu osobnih podataka mora imati znanje eksperta i praktično iskustvo vezano uz zaštitu osobnih podataka te mora dobro razumjeti Uredbu za zaštitu osobnih podataka. Službenik za zaštitu osobnih podataka ima obvezu: - informirati i savjetovati voditelja obrade/izvršitelja obrade o njihovoj obvezi sukladno novoj Uredbi kao i ostalim odredbama odnosnima na zaštitu osobnih podataka u EU ili državi članici; - nadzirati da postupanje sa osobnim podacima bude u skladu s Uredbom; - dizati razinu svijesti o značaju zaštite osobnih podataka i podučavati osoblje koje je uključeno u obradu osobnih podataka; - pružati savjete vezano uz procjenu rizika na zaštitu osobnih podataka; - nadzirati implementaciju politike upravljanja i upravljanje zbirkama osobnih podataka, - surađivati sa nadzornim tijelom za zaštitu osobnih podataka (Agencijom za zaštitu osobnih podataka). Općom uredbom o zaštiti podataka (GDPR) određeni voditelji obrade i izvršitelji obrade dužni su imenovati službenika za zaštitu podataka. To vrijedi za sva tijela javne vlasti i javna tijela (bez obzira na to koje podatke obrađuju) i za ostale organizacije čija je osnovna djelatnost sustavno i opsežno praćenje pojedinaca ili koje obrađuju posebne kategorije osobnih podataka u velikoj mjeri. Čak i kad se Općom uredbom o zaštiti podataka izričito ne zahtijeva imenovanje službenika za zaštitu podataka, za organizacije može biti korisno dobrovoljno imenovanje službenika za zaštitu podataka.