MediWales LifeStories Magazine 2021

Page 52

Success stories from the life science industry

Audit by a data protection authority: How does it work? It has been more than two years since Data Protection Authorities of EU Member States (DPAs) started to perform data protection audits. As part of their general task of monitoring compliance with the principles laid down by the General Data Protection Regulation (GDPR), each competent DPA may carry out inspections and impose sanctions. Whether you are a data controller or processor, you may therefore be subject to an audit at any time. This is why all organisations need to be ready now.

How does an audit work? A DPA audit may occur generally as a result of a complaint or request from a data subject, following a breach notification, or if the competent authority finds or suspects a noncompliance with the GDPR.

In practice, there are two types of audits: survey inspection (the audit is carried out on the basis of documents, at a hearing or online) or field inspection (the audit is carried out on site on the basis of information with physical inspection at the controller’s facilities). Consequently, an audit does not necessarily imply a visit of the DPA’s agents to the company premises.

The scope of the DPA’s audit is particularly wide. Xavier GOBERT, CEO of MyDataTRUST, says: ”DPA’s agents can come at any time and without even giving you prior notice of their arrival. It is therefore essential to have your GDPR file ready to be made available to them at their first request. In the context of an audit by the CNIL, the French DPA, particular attention was paid to the DPO, his skills and qualifications, as well as his effective role within the company. The CNIL then checked all contracts with customers and service providers, procedures, records of data processing activities, security measures and training records. They even interviewed staff members on the concrete implementation of GDPR procedures.” In this context of onsite visits, DPAs have a number of means to control data controllers and processors. In particular, they are authorised to consult and request copies of documents, to interview staff members, and to examine and print electronic documents. They can also carry out checks on tools, data supports or information systems used for data processing, and they can also request written or oral clarifications.

After DPAs have assessed the extent to which you comply with the relevant data protection requirements, they will provide you a risk-focused report with recommendations. “We received a report three weeks after the CNIL audit and a report of the visit three months later”, highlighted Xavier GOBERT. Following the German DPA, the main objective of an audit is not to issue fines but to determine where organisations still have compliance gaps and requirements. However, if the DPA audit is conducted subsequently to a violation, the DPA can impose a fine up to €20 million or up to 4% of the total annual worldwide turnover, taking into account the severity, the nature and the duration of the violation. It will also consider if the violation has been caused by intention or negligence. In addition to the financial risk, such an audit can affect your reputation and your brand image. The continuity of your business may even be jeopardised. In conclusion, what should you keep in mind? Don’t wait any longer – get ready today for a potential DPA audit! MyData-TRUST can help you.

www.mydata-trust.com

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Articles inside

Supporting the research response to COVID-19: The COPE Cymru study

2min
pages 72-73

Researchers venture into Covid hotspots to recruit patients for unique study

5min
pages 70-71

Study into antibiotic use wins research paper of the year prize

3min
page 69

€1.5 million project aims to work with 3,000 women to study impact of sex hormone changes on mental health

1min
page 67

How HCEC collaborates to innovate and translate valuable research into practice for patient and public benefit

4min
page 66

Projects developing the next generation of cancer therapeutics

2min
page 68

Achieving the remarkable: supporting and delivering COVID-19 research in Wales

3min
pages 64-65

New investment in the Life Sciences Research Network Wales

2min
page 63

Customised knee implant pioneered by TOKA®, Accelerate and Cardiff University Biomechanics Research Facility

2min
page 62

Design Studio Services help Cortigenix commercialise a new test providing early warning of potential health and fertilify issues

3min
pages 60-61

Taking science to Westminster Welsh biotech firm secures further investment for next-generation cancer therapies

2min
page 58

Harnessing technology to clear the surgical backlog

2min
page 56

Consult Smartly: reducing the outpatient waiting list backlog

3min
page 55

Space2B at The Maltings

1min
page 57

The world’s first ingestible supplement to help manage eczema and dry skin

2min
page 53

RedKnight helps secure grant for med-tech start-up’s rapid COVID-19 diagnostic

2min
page 54

Audit by a data protection authority How does it work?

2min
page 52

NHS and industry collaborate to improve compression garments

2min
page 50

Pandemic musings from Greaves Brewster

4min
page 49

Redefining the field of flexible endoscopy

2min
page 46

Business growth for Cryo Storage Solutions

1min
page 47

Bollé forms partnership with Welsh manufacturer

3min
pages 44-45

Evolve Raybotix UV-C Disinfection Robots at Techniquest

2min
page 48

High quality PPE masks: Made in the UK for the UK

2min
page 42

Blue Stream Academy - Supporting the health and care sector throughout the pandemic and beyond

2min
page 43

Keeping patients safe int he community using a portable 6 lead ECG device

2min
page 41

Facilitating advanced therapies by streamlining the value chain

2min
page 40

Bringing multimodal AI to healthcare

2min
page 38

PCI Pharma’s game-changing digital platform

3min
page 39

Developing breath analysis into a rapid diagnostic

2min
page 37

Safe endoscopy starts with the SNAP Endoscope Guide

2min
pages 32-33

Investment in sustainable manufacturing initiatives

2min
page 36

Scale-up for medical device contract manufacturing in Cardiff

3min
pages 34-35

SolasCure announces £15m Series A raise

2min
page 31

Cytiva: the life sciences company opening a new factory in Cardiff

3min
pages 28-30

Abel + Imray: 150 years protecting ideas

2min
page 27

Celtic connections turn brilliant ideas into practical reality

2min
page 26

Swansea University Academies driving global healthcare transformation

8min
pages 21-25

Respiratory Innovation Wales

3min
page 18

Talking Type 1: Books to support psychological needs of people living with diabetes

2min
page 20

Health Technology Wales

1min
page 19

Innovation that matters: Working with the NHS to improve pregnancy care

3min
page 16

Award winning SBRI Centre of Excellence goes from strength to strength

3min
page 17

Why digital technology is now more important than ever for healthcare in Wales

4min
page 15

Video consulting in NHS Wales rated highly by patients and clinicians

2min
page 13

Digital Health and Care Wales: Technology at the heart of NHS Wales’ response to the pandemic

3min
page 14

Journey to joint QMS accreditation for manufacture of medical devices in two NHS Wales services

2min
page 12

Introducing a locally designed electronic ureteric stent register

4min
page 9

Helping people with mental health problems to find and remain in work

4min
pages 10-11

TriTech Institute supports the development of new healthcare solutions

3min
page 7

Innovative digital bike to encourage exercise

1min
page 8

Velindre Cancer Centre in fluorouracil based chemotherapy genetic screening first

2min
page 6
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