Chapter 591
Fil-qosor
Din il-liġi tistabbilixxi l-Awtorità Maltija għall-Innovazzjoni Diġitali biex tappoġġja l-iżvilupp u l-implimentazzjoni ta' prinċipji gwida għat-teknoloġija innovattiva u biex teżerċita funzjonijiet regolatorji. L-għan ewlieni tagħha huwa li tippromwovi t-teknoloġija innovattiva f'Malta u tirregola s-servizzi relatati magħha.
X'tirregola
- L-istabbiliment u l-funzjonijiet tal-Awtorità Maltija għall-Innovazzjoni Diġitali.
- Il-prinċipji gwida għall-iżvilupp u l-użu tat-teknoloġija innovattiva.
- Il-funzjonijiet regolatorji dwar it-teknoloġija innovattiva u s-servizzi relatati.
- Il-promozzjoni ta' fiduċja, trasparenza, affidabbiltà, robustezza, sigurtà u awditabilità fit-teknoloġija innovattiva.
Min hu kkonċernat
- L-Awtorità Maltija għall-Innovazzjoni Diġitali u l-uffiċjali tagħha.
- Żviluppaturi ta' teknoloġija innovattiva, b'mod partikolari, iżda mhux esklussivament, start-ups u intrapriżi żgħar u ta' daqs medju.
- Utenti ta' teknoloġija innovattiva u l-pubbliku inġenerali.
Punti ewlenin
- L-Awtorità hija magħmula minn Bord b'Chairperson u mhux inqas minn erba' (4) u mhux aktar minn tmienja (8) membri oħra.
- Il-membri tal-Bord jinħatru għal terminu ta' sena jew sa massimu ta' tliet snin, u jistgħu jerġgħu jinħatru.
- L-Awtorità għandha l-għan li tipproteġi l-interessi tal-utenti u l-pubbliku, inklużi utenti fi kwalunkwe pajjiż u mhux esklussivament f'Malta.
- Il-liġi tippromwovi l-iżvilupp tat-teknoloġija innovattiva f'diversi setturi ekonomiċi u soċjali, bħal servizzi finanzjarji, saħħa, edukazzjoni, u amministrazzjoni pubblika.
Legal text
MALTA DIGITAL INNOVATION AUTHORITY CHAPTER 591 MALTA DIGITAL INNOVATION AUTHORITY ACT AN ACT to provide for the establishment of an Authority to be known as the Malta Digital Innovation Authority, to support the development and implementation of the guiding principles described in this Act and to promote consistent principles for the development of visions, skills and other qualities relating to innovative technology, and to exercise regulatory functions regarding innovative technology and related services and to provide for matters ancillary thereto or connected therewith. Substituted by: XIX.2024.
- 15th July, 2018 ACT XXXI of 2018., as amended by Act XIX of
- ARRANGEMENT OF THE ACT Part I Part II Part III Part IV Part V Part VI Part VII Part VIII Part IX Part X Part XI First Schedule Second Schedule Articles Preliminary 1–2 Guiding Principles 3–4 Establishment, Functions and 5 – 10 Conduct of Affairs of the Authority Officers and Employees of 11 – 12 the Authority Financial Provisions 13 – 25 Principles relating to 26 - 33 Recognition Deleted by Act No. XIX of 34 - 38 Enforcement and Sanctions 39 - 44 Administrative Review 45 - 54 Tribunal Deleted by Act No. XIX of 55 - 57 Miscellaneous Provisions 58 – 59 Innovative Technology Deleted by Act No. XIX of Substituted by: XIX.2024.
- PART I Preliminary
- The short title of this Act is the Malta Digital Innovation Authority Act. 2.
- a)in full respect of the importance of not hindering innovation and the efforts and potential of small and mediumsized enterprises and the start-up sector in this area of activity; (
- b)while considering that the approach to recognition and regulation may be moderated by the pace of changes and developments taking place in this sector; (
- c)in a manner ensuring that there are standards in place for the protection of users, the integrity of the market, and the public interest in general; (
- d)in a manner that incentivises innovation and innovative technology development in or from Malta; (
- e)in a manner that is consistent with European and international laws applicable to Malta; and (
- f)in line with the values outlined in the strategy of the Authority or similar document, as may be updated from Promotion and development of the Authority’s interests. Substituted by: XIX.2024.7. MALTA DIGITAL INNOVATION AUTHORITY time to time. Main policies and objectives. Amended by: XIX.2024.8. 4.
- a)to promote governmental policies that favour the deployment, within the public administration, of innovative technology by the Government where necessary or appropriate; (
- b)to foster, promote and facilitate the advancement and utilisation of innovative technology through, amongst others, programmes and schemes, such as, but not limited to, a controlled regulatory environment for the testing of innovative technology, aimed at incentivising innovative technology development in and from Malta and the creation of trust in innovative technology; (
- c)to assist developers of innovative technology, in particular, but not exclusively, start-ups and small and medium-sized enterprises in meeting their regulatory and other obligations, and to minimise risks to, and posed by, innovative technology, by issuing recognitions and through other programmes and incentives designed for this purpose; (
- d)to promote, through grants, programmes, research, education, use and, or the making available of facilities, hardware or personnel, the use and development of innovative technology and the application of ethical standards in the development and use of such innovative technology: Provided that the giving of such grants shall not prejudice and, or preclude the Authority’s oversight and regulatory functions and powers; (
- e)to promote, and strive to safeguard, maintain and protect the reputation of Malta in relation to innovative technology and the development and use of innovative technology; (
- f)to protect the interest of users of innovative MALTA DIGITAL INNOVATION AUTHORITY technology and the public in general and in so doing take any necessary action, including without limitation to disclosure of information and documents which the Authority in its discretion deems that merits disclosure and, or when required by law, to be disclosed to the general public and, or referred to any other competent authority and the pursuance of any further act or collaboration from or with other public entities, regulatory bodies and, or competent authorities and, or regulatory bodies; (
- g)to provide a sound financial basis to the Authority, through, amongst others, the levying of fees by the Authority, including the imposition of interest in the case of late payment at the rate to be determined by the Authority, for the Authority to be able to achieve its purposes; (
- h)to promote harmonised practices and, where applicable, to facilitate the adoption of standards in innovative technology in Malta in conformity with international norms, standards, rules and, or laws and particularly with those of the European Union; (
- i)to assist the competent data protection authorities as required by law; (
- j)to promote and encourage ethical and legitimate criteria in the design and use of innovative technology, and to enforce, as deemed necessary, the quality of services and security of the innovative technology for which a recognition has been granted by the Authority; (
- k)through collaboration with other regulatory bodies and competent authorities with responsibility for the prevention of money laundering and the financing of terrorism and crime in general, to support the prevention of money laundering, terrorist financing and the commission of any other crime in, or by means of the use of innovative technology; (
- l)to promote trust, transparency, reliability, robustness, safety and auditability in the design and use of innovative technology; (
- m)to promote legal certainty in the application of laws, in a national and cross-border context, and the development of appropriate legal principles for the effective application of law to innovative MALTA DIGITAL INNOVATION AUTHORITY technology; and (
- n)to promote security by design and security by default criteria with reference to innovative technology.
- a)"security by design" means measures adopted at the earliest stages of the design and development of innovative technology, and also throughout its lifetime, to protect its security to the highest possible degree; and (
- b)"security by default" means the default configuration of innovative technology to the most secure settings possible. PART III Establishment, Functions and Conduct of Affairs of the Authority Establishment and composition of the Malta Digital Innovation Authority. Amended by: XIX.2024.9. 5.
- a)is a Minister, Parliamentary Secretary or a member of the House of Representatives; or (
- b)is a judge or magistrate of the courts of justice; or (
- c)has a financial or other interest in any enterprise or activity which is likely to affect, in a general manner, the discharge of his functions as a member of the Board as a result of a conflict of interest: Provided that should any nominee to such a position declare a conflict of interest or potential conflict of interest based on a specific context only and provides full information, this may be reviewed by the Minister and the Board, and if the conflict of interest is not considered one which would disqualify the nominee, this disqualification shall not apply but it shall be the subject of a written guidance on the part of the Minister, and, or the Board which shall apply to the member for as long as such specific context subsists, and this without prejudice to sub-article
- a)at the expiration of his term of office; or (
- b)if any circumstances arise that, if he were not a member of the Board, would cause him to be disqualified for appointment as such. MALTA DIGITAL INNOVATION AUTHORITY
- a)if the member due to infirmity of mind or of body or for any other cause is effectively unable to continue to discharge his duties as a member; (
- b)if the behaviour or performance of the member brings into question his suitability or ability to continue as a member, in particular for behaviour that affects or may affect his reputation, independence or autonomy, or the reputation, independence or autonomy of the Authority; (
- c)if any member fails to perform his duties for a continuous period exceeding five
- a)publish and administer such programmes, schemes and initiatives that, in its view, are necessary to promote the interests of the innovative technology sector and its users, including, but not limited to, schemes of recognition whereby, amongst others, the innovative technology, and the risks posed by its application are assessed and tested and provided with a certificate or mark of assurance or approval, in any manner that they are referred to: Provided that the Authority shall publish the terms of such programmes, schemes and initiatives in a clear and transparent manner; (
- b)unless otherwise determined by or under any applicable laws and, or regulations, determine those professional services related to innovative technology that require recognition by the Authority and publish and administer such programmes, schemes and initiatives that, in the view of the Authority, are necessary to foster trust in innovative technology, including services for the auditing and testing of innovative technology, or aspects thereof, and the risks posed by their use or application; (
- c)publish and administer such programmes, schemes and initiatives, including those ensuring that a controlled regulatory environment for the testing of innovative technology is available, for the fostering of the development of innovative technology in or from Malta; (
- d)obtain from the Government, other local authorities or agencies and, or apply to the European Union or other international bodies for the grant of funds to be utilised as grants to be allocated to innovative technology by way of incentives and awards and administer such grants and incentives to applicants Purpose, functions and powers of the Authority. Amended by: XIX.2024.10. MALTA DIGITAL INNOVATION AUTHORITY in accordance with fair, transparent and nondiscriminatory conditions to be published by the Authority and which are accessible through the website of the Authority, from time to time; (
- e)perform the functions of the National Cybersecurity Certification Authority in accordance with Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No. 526/2013 (Cybersecurity Act), and advise the Minister on the adoption and publication of laws necessary to implement European and international laws relating to cyber security certification; (
- f)be consulted on any planned implementation of laws and policies relating to the national imposition of obligations on innovative technology in any area or sector as well as in relation to the implementation of European Union and, or international legislation relating to innovative technology; (
- g)subject to any limitations that may be imposed on the powers of the Authority, establish and levy fees in relation to innovative technology, including on any recognition and any persons, such as providers of services relating to innovative technology participating in the initiatives and, or schemes published or administered by the Authority, whether acting alone as well as jointly with other public entities, regulatory bodies and, or competent authorities, subject to the publication of such fees in advance and in a transparent fashion and accessible through the website of the Authority, and the Authority shall also have the power to establish and levy fees for services rendered to other public entities, regulatory bodies and, or competent authorities; (
- h)regulate, issue recognitions and conditions, including in principle temporary or partial recognitions, as may be further elaborated by the Authority pursuant to its guidelines and test, monitor and supervise innovative technology, in or from Malta, in accordance with the Act and any subsidiary legislation made thereunder; MALTA DIGITAL INNOVATION AUTHORITY (
- i)keep under review all practices, operations and activities relating to any matter regulated by or under the Act or any other law which the Authority is entitled to administer or enforce or any European Union and, or international legislation applicable to Malta; (
- j)promote high standards of conduct and governance throughout the innovative technology industry, corresponding with the levels of risk posed by the use of innovative technology; (
- k)enforce compliance with obligations and, or terms arising from and, or in terms of the law; (
- l)own, manage, supervise and control and as required use, hold, develop and provide, maintain a sublicence and, or make available any wallet or similar solution or software, any wallet solution, account or other facility, in particular in relation to any form of digital identity, accreditation, data and digital assets; (
- m)engage with facilities, entities and persons, including service providers and carry out transactions as it may consider necessary for the fulfilment of its functions, and enter into any contract for the supply of goods or materials or the execution of work or the rendering of services to, or for the benefit and, or functioning of the Authority, including but not limited to, in pursuance to paragraph (
- l)and, or the innovative technology sector; (
- n)monitor the effects of laws on the use and operation of innovative technology and undertake or commission such study, research or investigation which it may deem necessary in this regard; (
- o)issue binding documentation such as guidelines and provide information and guidance on any matter, including definitions regulated by, or under the Act, or any other law which the Authority is entitled to administer or enforce, or any European Union and, or international legislation applicable to Malta; (
- p)determine, by virtue of guidelines or other binding documentation, which products, solutions or services may be classified as "innovative technology" as defined in the Act and the purposes, qualities, features, attributes, behaviours or aspects MALTA DIGITAL INNOVATION AUTHORITY thereof that shall be recognised by the Authority; (
- q)support and liaise with non-profit organisations and educational institutions in Malta which are established for the promotion of the use and development of innovative technology; (
- r)keep under review developments on relevant subjects relating to innovative technology in order to ensure that activity in Malta is generally consistent with internationally recognised standards and norms of good practice; (
- s)enter into agreements with other public bodies and authorities to better coordinate the effective and efficient exercise of the respective functions of such public bodies and authorities where they have common functions, interests or aims, including the delegation to the Authority by the said public bodies and authorities of certain powers appertaining to them and the delegation by the Authority to such other public bodies and authorities of certain powers of the Authority; (
- t)collect relevant statistical and other information as may be required by the Authority in relation to innovative technology; (
- u)perform such other functions, including functions aimed at promoting innovative technology, as may from time to time be assigned to it by the Minister, or by governmental or ministerial appointment or by engagement by other public entities, regulatory bodies and, or competent authorities; (
- v)impose administrative penalties and, or measures and, or fines in accordance with the powers of the Authority in relation to a breach of the Act, any regulations made thereunder, any law which the Authority is entitled to administer or enforce, or any recognition issued by the Authority or any European Union and, or international legislation applicable to Malta; (
- w)advise the Minister on the formulation of policy in relation to matters regulated by, or under the Act, and in particular in relation to any international obligations; (
- x)otherwise advise the Minister on any matter connected with its functions under the Act or any MALTA DIGITAL INNOVATION AUTHORITY other law; (
- y)formulate and implement the policies and strategies with short-term and long-term objectives in relation to the matters connected with its functions under the Act or any other law; (
- z)encourage users of innovative technology to establish places of business in Malta; (
- aa)advise the Minister on the planning and development of the innovative technology industry as well as on the infrastructure supporting the innovative technology industry; (
- bb)promote and advance Malta as a destination for high value commercial users of innovative technology to establish places of business in Malta; (
- cc)prescribe any forms relating to any of the applications and processes involved in the recognition of innovative technology; (
- dd)establish or participate in the establishment and operation of entities whose function shall be necessary, ancillary or conducive to the attainment of the functions and, or objectives of the Authority under the Act or any regulations made thereunder or any law which the Authority has the power to administer or enforce or any European Union and, or international legislation applicable to Malta; (
- ee)perform the functions of a competent authority in accordance with Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) for data altruism services and data intermediation services; (
- ff)carry out functions in line with cooperation mechanisms with other national competent authorities; and (
- gg)appoint a qualified person or otherwise require that the person concerned appoints a qualified person in the case that he considers this to be appropriate or expedient to perform those tasks in terms of those terms and conditions that the Authority may order. The fees and expenses incurred by the qualified person in this respect or which are incidental to MALTA DIGITAL INNOVATION AUTHORITY such an appointment shall be paid by the person in respect of whom the qualified person was appointed, unless determined otherwise by the Authority. The Authority may issue guidelines that establish the procedures or requisites related with this appointment and these guidelines may also establish the powers, duties and obligations of the qualified person.
- a)Without prejudice or limitation to any of the powers of the Authority, the Authority shall have the power, strictly for the purposes of carrying out its functions, to request any person or any person who may have in her possession relevant documentation to provide it with any information, documents and reports, including financial information, that the Authority considers necessary: Provided that the information requested by the Authority shall be proportionate to the performance of its functions and obligations under the Act or any regulations made thereunder or any law which the Authority has the power to administer or enforce or any European Union and, or international legislation applicable to Malta, and in requiring any information as aforesaid, the Authority shall specify the reason for such request. (
- b)Where the Authority requires information relating to the intellectual property, trade secrets or commercially sensitive information related to any innovative technology, it shall only demand that information which is strictly necessary for its purposes and shall keep such information confidential. (
- c)A person who is notified with a request for information shall comply promptly with the request and within the timeframes and according to any level of detail, as may be required by the Authority. (
- d)Any person who has any information requested by the Authority in terms of the Act and its officers or employees shall, on a written request from the Authority, provide expeditiously to the Authority any information required by the Authority in terms of the Act, may not raise in this regard, an exception or defence including any obligation with regard to the prohibition or the confidentiality that arise from contractual law or in any other manner refuses to conform with such a request from the Authority. No action for a breach of contractual law or disciplinary action may be taken in a direct or MALTA DIGITAL INNOVATION AUTHORITY indirect manner by a person in regard to officers and employees due to the fact that they provided the Authority with any required information by the Authority as provided in sub-article
- a)The Authority may opt to publish information and, or guidelines relating to its rulings and determinations which are accessible through the website of the Authority when said rulings and determinations affect applications, the interpretation of the provisions of the Act, or any law which it has the power to administer or enforce or any European Union and, or international legislation applicable to Malta, in order to ensure that applicants and the public in general are aware of the position taken by the Authority on matters of general interest relating to innovative technology. (
- b)The publication of such information and, or guidelines shall not in any way limit the freedom of the Authority to vary its policies or approach on any issue based on further review and experience or development of innovative technology or law generally. When such variations take place the Authority shall notify in later publications the connection and review to previous publications. (
- c)The Authority shall have the power to determine when any of its publications, or part thereof, shall become binding.
- a)require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product’s compliance with applicable European Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof; (
- b)require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under European Union harmonisation legislation; (
- c)require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation; (
- d)carry out unannounced on-site inspections and physical verifications; (
- e)enter any premises, land or means of transport that the economic operator in question used for purposes related to the economic operator’s trade, business, craft or profession, in order to identify non-compliance and to obtain evidence; (
- f)start investigations on its own initiative in order to identify non-compliance and ensure that the situation is rectified; (
- g)require economic operators to take appropriate MALTA DIGITAL INNOVATION AUTHORITY action to stop circumstances of non-compliance or to eliminate the risk; (
- h)take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including by prohibiting or restricting the making available of a product on the market or by ordering that the product is withdrawn or recalled; (
- i)impose administrative penalties in accordance with Article 41 of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011 and according to European Union legislation; (
- j)acquire product samples, including under a cover identity, to inspect those samples and reverse engineer them in order to identify non-compliance and to obtain evidence; (
- k)where no other effective means are available to eliminate a serious risk: (
- i)to require the removal of content referring to the related products from an online interface or require the explicit display of a warning to end users when they access an online interface; or (
- ii)where a request according to subparagraph (
- i)has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures; and (
- l)use any information, document, finding, statement, or any intelligence as evidence for the purpose of its investigations, irrespective of the format in which and medium on which they are stored.
- a)have control of the general administration, supervision and operations of the Authority and any ancillary activity related to it; (
- b)develop the necessary strategies for the implementation of the objectives of the Authority and implement such strategies as directed by the Board; (
- c)advise the Board on any matter it may refer to him or any matter he considers necessary or expedient; (
- d)perform such other duties as the Board may assign to him from time to time; and (
- e)at the end of each financial year, present to the Board estimates of the income and expenditure of the Authority for the following financial year for the Board’s approval.
- Without prejudice to the other provisions of this Act, the Authority shall appoint and employ, at such remuneration and upon such terms and conditions as it may establish with the concurrence of the Minister, such officers and employees of the Authority as may from time to time be necessary for the due and efficient discharge of the functions of the Authority. Officers and employees deemed to be public employees and public officers. Cap. 595.
- All officers and employees of the Authority shall be deemed to be public employees within the meaning of the Public Administration Act and shall be considered to be public officers as defined in article 124 of the Constitution for the purposes of the Criminal Code or any other law. MALTA DIGITAL INNOVATION AUTHORITY PART V Financial Provisions 13.
- a)until the expiration of six months from the beginning of a financial year, or until the approval of the estimates for that year by the Minister, whichever is the earlier date, the Authority may make or incur expenditure for carrying out its functions under this Act or any other law which the Authority is entitled to administer or enforce not exceeding in the aggregate one-half of the amount approved by the Minister for the preceding financial year; (
- b)expenditure approved in respect of a head or sub- head of the estimates may, with the approval of the Minister, given after consultation with the Minister responsible for finance, be made or incurred in respect of another head or sub- head of the estimates; (
- c)in respect of the first financial year, the Authority may make or incur expenditure not exceeding in the aggregate such amounts as the Minister responsible for finance may, after consultation with the Minister, allow; (
- d)if in respect of any financial year it is found that the amount approved by the Minister is not sufficient or a need has arisen for expenditure for a purpose not provided for in the estimates, the Authority may adopt supplementary estimates for approval by the Minister and in any such case the provisions of this Act applicable to the estimates shall as near as practicable apply to the supplementary estimates. 19. The Minister shall, at the earliest opportunity and not later than three months after he has received a copy of the estimates and supplementary estimates of the Authority, or if at any time during that period the House of Representatives is not in session, within three months from the beginning of the next following session, cause such estimates to be laid on the Table of the House of Publication of approved estimates. MALTA DIGITAL INNOVATION AUTHORITY Representatives. Accounts and audit. Amended by: XIX.2024.18. 20.
- a)the manner in which and the officer or officers by whom payments are to be authorised or approved; MALTA DIGITAL INNOVATION AUTHORITY (
- b)the title of any account held with the bank or banks into which the monies of the Authority are to be paid, and the transfer of funds from one account to the other; (
- c)the method to be adopted in making payments out of funds of the Authority, and generally with respect to any matter which is relevant to the proper keeping and control of the accounts and books, and the control of the finance, of the Authority. 22. Repealed by Act XIX.2024.20. 23. The Authority shall, not later than three months after the end of each financial year, make and transmit to the Minister and to the Minister responsible for finance a report dealing generally with the activities of the Authority during that financial year and containing such information relating to the proceedings and policy of the Authority as either of the said Ministers may from time to time require. The Minister shall, at the earliest opportunity and not later than three months after he has received a copy of every such report, or if at any time during that period the House of Representatives is not in session, within three months from the beginning of the next following session, cause a copy of every such report to be laid on the Table of the House of Representatives. 24. Repealed by Act XIX.2024.21. Contracts of supply or works. Annual Report. Money laundering. 25. The Authority and any Board member, officer or employee of the Authority, and any other person appointed to perform a function under this Act or any other law which the Authority is entitled to administer or enforce, or under any rules or regulations made thereunder, shall not be liable in damages for anything done or omitted to be done in the discharge or purported discharge of any functions in accordance with the powers of the Authority unless the act or omission is proven to have been done or omitted to be done in bad faith. Exclusion of liability. Amended by: XIX.2024.22. PART VI Substituted by: XIX.2024.23. Principles relating to Recognition 26.
- a)the form of recognition and the programme, initiative and, or scheme under which it is granted; (
- b)each innovative technology product, solution or service which is recognized; (
- c)all such details as the Authority shall consider necessary to identify the relevant recognition holder; and (
- d)the information on all matters which is required to be entered into the register for public information in accordance with the provisions of the Act, any other applicable law, or which the Authority deems to be in the public interest and such information shall be updated on a regular basis. Power of the Authority to grant or refuse recognition. Amended by: XIX.2024.25. 27.
- a)The Authority, when granting a recognition, may subject it to such conditions as it may deem appropriate, and having granted such recognition it may, from time to time, vary or revoke any condition so imposed or impose new conditions. (
- b)For the better carrying out of the provisions of the Act, the Authority may, from time to time, issue and publish recognition conditions, rules and guidelines which shall be binding on recognition MALTA DIGITAL INNOVATION AUTHORITY holders as may be specified therein. (
- c)In the interest of transparency and market awareness, such recognition, conditions, rules and guidelines may lay down, amongst others, additional requirements and conditions in relation to the activities of applicants and recognition holders and any other matters as the Authority may consider appropriate.
- a)the protection of the general public and organisations; (
- b)the protection of the reputation of Malta taking into account Malta’s international commitments; (
- c)choice; and the promotion of innovation, competition and (
- d)the reputation and suitability of the applicant and all other connected parties.
- a)if the application is not submitted in accordance with the established form or in accordance with applicable procedure; or (
- b)if the applicable fees have not been paid; or (
- c)if the Authority, in its discretion, is not satisfied that the applicant, any relevant persons, including persons with delegated authority of representation, possess the required qualities and, or competencies and, or qualifications, including those relating to security features and automated technology systems used and those related to fit and proper requirements, imposed by the Authority; or (
- d)Repealed by Act XIX.2024.26. Refusal to grant recognition. Amended by: XIX.2024.26. MALTA DIGITAL INNOVATION AUTHORITY (
- e)if it transpires that any information or submission made to the Authority is false, misleading, inaccurate or incomplete in a material respect; or (
- f)if the Authority, in its discretion is not satisfied in accordance with the circumstances of the case that: (
- i)the applicant is capable of sustainably financing the innovative technology; (
- ii)the applicant has the necessary competence, technical know-how and resources to develop the innovative technology or provide the service; (iii) the applicant has a business model to develop and, or maintain the innovative technology or provide the service in a viable manner which is compliant with the applicable regulatory instruments in force; and (
- iv)the applicant shall comply with all requirements and obligations applicable should a recognition be issued by the Authority, including but not limited to financial safeguards; or (
- g)if the Authority believes that the applicant’s proposal is not compliant with the regulatory instruments in force; (
- h)if the Authority believes that granting a recognition to the applicant may pose a risk to the reputation of Malta or is otherwise not in the public interest or contrary to regulatory objectives established by the Act; (
- i)if the Authority believes that the innovative technology may be used in a manner that is contrary to public morality, or third party personal rights or is considered a potential security threat, or may pose a risk to the reputation of Malta, or is considered to be not in the public interest; or (
- j)if the Authority, in its reasonable discretion, is not satisfied that the applicant has complied with and, or has satisfied the required conformity assessment procedure, where applicable and, or other procedures of the Authority. MALTA DIGITAL INNOVATION AUTHORITY
- The Authority shall, within a time period to be established through guidelines, which period may vary depending on the type of recognition, notify an applicant in writing of its decision to refuse an application for recognition. Notice of refusal of a recognition. Substituted by: XIX.2024.
- 30.
- a)one of the grounds for which the Authority may have rejected the recognition holder’s application arises; (
- b)where the recognition is issued based on incorrect or false information provided to the Authority; (
- c)where at the discretion of the Authority, this is in the interest of the users of the innovative technology concerned, public safety or morality, or the reputation of Malta; (
- d)where this is necessary as a result of a change in the legal framework which necessitates such a revocation, cancellation or suspension of recognition; or (
- e)where this is necessary on the basis of European Union and international laws applicable to Malta: Provided that without prejudice to any other breaches under any other law that this may give rise to, the providing of false information to the Authority shall constitute an offence in accordance with the Act and shall be punishable in accordance with the provisions of the Act.
- a)represents an immediate and serious threat to the users of the innovative technology, the public interest or to the application of mandatory rules of law; (
- b)creates or may create serious economic or operational problems for third parties, in particular other providers or users of innovative technology; and, or (
- c)would result in harm to Malta and, or the European Union and, or the welfare of users and, or competition, including within the innovative technology sector, the Authority may take urgent measures including ordering the immediate cessation of the act or omission giving cause to the infringement and the imposition of administrative penalties and the suspension, revocation or cancellation of the recognition. Decisions of the Authority. Substituted by: XIX.2024.30. 32.
- Repealed by Act XIX.2024.
- Transferability. PART VII Regulatory Powers
- Repealed by Act XIX.2024.
- Power of competent authority to revoke, cancel or suspend innovative technology arrangement authorisations and innovative technology services authorisations.
- Repealed by Act XIX.2024.
- Procedure when taking a measure under article
- Repealed by Act XIX.2024.
- Notification of proposed refusal, revocation, cancellation or suspension of an innovative technology authorisation.
- Repealed by Act XIX.2024.
- Publication of policy guidelines.
- Repealed by Act XIX.2024.
- Exemptions. PART VIII Enforcement and Sanctions
- Repealed by Act XIX.2024.
- 40.
- a)enter, at any reasonable time, any premises or any other place or any vehicle or vessel where any activity regulated by or under this Act or any other law which the Authority is entitled to administer or enforce, takes place, or in the opinion of the Authority takes place, and search and inspect the premises, place, vehicle or vessel and any books, documents or records found therein; Provision of information. Enforcement powers of the Authority. Amended by: XIX.2024.34. MALTA DIGITAL INNOVATION AUTHORITY (
- b)require any person to produce for inspection and take extracts or copies from any books, documents or records relating to any activities regulated by or under this Act or any other law which the Authority is entitled to administer or enforce, which are under the control of that person and, in the case of information in a non-legible form to reproduce it in a legible form, and to give to the Authority such information as the Authority may reasonably require in relation to any entries in such books, documents or records; (
- c)remove and retain such books, documents or records for such period as may be reasonable for further examination; (
- d)require any person to maintain such books, documents or records for such period as may be reasonable as the Authority directs; (
- e)require any person to give to the Authority any information that may be required with regard to any matter regulated by or under this Act or any other law the Authority is entitled to administer or enforce; (
- f)make such inspections, including site inspections, to enable the Authority to carry out its functions at law and in doing so the Authority may also undertake tests and measurements of any machinery, apparatus, appliances and other equipment at any place as the Authority may consider necessary: Provided that where the person concerned fails to abide with any requirements made by the Authority under this sub-article, the Authority may then take any such measures as it may consider appropriate in the circumstances including the switching off or modification of the use of any such apparatus; and (
- g)investigate any suspected breach of any obligations arising under the Act or any other law which the Authority is entitled to administer or enforce or any European and, or international legislation which is applicable in Malta: Provided that the Authority may initiate investigations on its own initiative.
- a)obstructs, impedes or assaults an officer of the Authority or any other person duly authorised by the Authority to act on its behalf in the exercise of any of the powers conferred by this Act or by any other law which the Authority is entitled to administer or enforce; (
- b)fails or refuses to comply with a requirement under this article; (
- c)alters, suppresses or destroys any books, documents or records which the person concerned has been required to produce, or may reasonably expect to be required to produce; (
- d)falsely represents himself to be an officer of the Authority or a person authorised by the Authority to act on its behalf; or (
- e)furnishes any information to the Authority which it may require in the exercise of its functions under the Act or any law it is entitled to administer or enforce, which he knows, or has reasonable cause to believe to be false or misleading, shall be guilty of an offence against this Act, and shall on conviction be liable to a fine (multa) not exceeding twelve thousand euro (€12,000) or to imprisonment for a period not exceeding three months, or to both such fine and imprisonment.
- Repealed by Act XIX.2024.
- Where an infringement of any provision of the Act or any other law which the Authority is entitled to administer or enforce is committed by a body corporate and is proved to have been committed with the consent or involvement of or to be attributable to MALTA DIGITAL INNOVATION AUTHORITY the gross negligence on the part of a person being an administrator of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be liable to be proceeded against and punished as if he was responsible for the said infringement.
- The prosecution of a criminal offence or the initiation of proceedings to impose an administrative penalty under the Act or under any other law which the Authority is entitled to administer or enforce shall be prescribed by the lapse of two years from the date on which the offence or infringement is alleged to have been committed. Prescription for offences and infringements. Amended by: XIX.2024.
- PART IX Administrative Review Tribunal 45.
- Appeals against an administrative penalty imposed by the Authority. Amended by: XIX.2024.
- MALTA DIGITAL INNOVATION AUTHORITY 47.
- Decisions of the Administrative Review Tribunal. Amended by: XIX.2024.
- In determining an appeal the Tribunal shall take into account the merits of the appeal, and may, in whole or in part, confirm or annul the decision appealed from, giving in writing the reasons for its decision and shall cause such decision to be made public and communicated to the parties to the appeal. Procedure of the Tribunal. Amended by: XIX.2024.
- 49.
- a)the urgency of the matter; (
- b)the effect on the party making the request if the application for suspension is not upheld; and (
- c)the effect on competition and, or on users of innovative technology if the application is upheld: Provided that a party, in making an application under this article, shall state the factual and legal grounds establishing a prima facie case for the suspension of the decision. The Tribunal or the Court of Appeal, as the case may be, shall on receipt of any such application order the notification thereof to the other party or parties to the appeal affording them reasonable opportunity to make their response thereto: Provided further that the Tribunal, in determining any such application, may include such conditions as it considers necessary in the circumstances. 50A. In cases where the Tribunal or the Court of Appeal, as the case may be, after having upheld an application to suspend an administrative penalty imposed by the Authority pending proceedings, decides that the administrative penalty is due, such administrative penalty shall be due together with any interests accrued thereon as from the date specified by the Authority for payment, including the period during which the payment of the said Accrual of interest. Added by: XIX.2024.46. MALTA DIGITAL INNOVATION AUTHORITY administrative penalty was suspended. Service of notices. Amended by: XIX.2024.47. 51. Where a notice, howsoever described, is required to be given by the Authority to any person whether under this Act or under any other law administered by the Authority, the notice shall be addressed to that person and shall be given to the person in any of the following ways: (
- a)by delivering it to the person; (
- b)by leaving it at the address at which the person ordinarily resides or carries on business; (
- c)by sending it by registered post to the person at the address at which the person ordinarily resides or carries on business; (
- d)if an address for the service of notices has been provided by the person, by leaving it at such address, or sending it by registered post addressed to the person to that address; (
- e)in any case that the Authority deems it necessary to send the notice by means of electronic mail, to the electronic mail address provided by the addressee to the Authority, provided that the notice shall not be deemed as delivered if the Authority receives an automated electronic mail delivery failure message, indicating that the electronic mail was not delivered: Provided that the provisions of this paragraph shall not apply to the service of documents filed before the Tribunal or any Court. Proceedings for debts due to the Authority. Amended by: XIX.2024.48. 52.
- a)any innovative technology has the recognition of the Authority, if this is not the case; Name of the Authority not to be used in any advertisement and prohibition of misrepresentation. Amended by: XIX.2024.49. (
- b)any activity carried out by any person or provided by or on an innovative technology has the recognition or is conducted with the co-operation or assistance of the Authority, if this is not the case; or (
- c)any activity is being carried out in, or from Malta in accordance with the regulatory framework applicable to innovative technology when the relevant product, solution or service is not recognised by the Authority; or similar statements based on the circumstances from time to time, and in case of breach such person shall be guilty of an offence under this article.
- a)an innovative technology is being administered and operated in or from Malta, or is being provided in or from Malta; (
- b)reference is made to such fact in an advertisement; and (
- c)the product, solution or service is not recognised by the Authority in any form, as the case may be. MALTA DIGITAL INNOVATION AUTHORITY
- a)not less than five thousand euro (€5,000) and not more than ten thousand euro (€10,000) if the person enjoys recognition by the Authority; and (
- b)not less than fifty thousand euro (€50,000) and not more than one hundred thousand euro (€100,000) if the person does not enjoy recognition by the Authority. Exemption from taxes. 54. Repealed by Act XIX.2024.50. PART X Co-ordination with other Competent Authorities; Simplification Co-ordination with other national competent authorities. 55. Repealed by Act XIX.2024.51. No duplication of controls and simplification of procedures. 56. Repealed by Act XIX.2024.51. Joint Regulatory Efficiency Board. 57. Repealed by Act XIX.2024.51. PART XI Miscellaneous Provisions Power of the Minister to make regulations and of the Authority to issue guidelines. Amended by: XIX.2024.52. 58.
- a)(
- i)define and empower the Authority to define products, solutions and services that may be regulated under the Act; (
- ii)regulate recognition processes in accordance with the Act or any other law which the Authority is entitled to administer or enforce or any European Union and, or international legislation applicable to Malta; and the overall requirements and conditions for such recognitions, their grant, amendment, renewal, suspension, revocation and termination and other similar actions and to further empower the Authority to lay down any such requirements and conditions; (
- b)empower the Authority to regulate and issue recognition to persons engaged in activities falling within the competence of the Authority, the Act or any other law which the Authority has the power to administer or enforce or any European Union and, or international legislation, and all matters relating thereto, including the qualifications and elements to provide innovative technology as well as the exemption of certain persons or categories of persons from any or all of the requirements for recognition; (
- c)establish methods of review relating to the processes and procedures adopted by the Authority in carrying out its functions; (
- d)provide for any administrative penalties that may be imposed by the Authority for any breach of the provisions of the Act or any other law which the Authority is entitled to administer or enforce or any European Union and, or international legislation applicable to Malta; (
- e)implement any international convention or any EU Regulation or Directive, to the extent necessary, to which Malta has adhered to in the context of the innovative technology sector; (
- f)lay down rules establishing any fees and tariffs which may be levied by the Authority; (
- g)lay down rules, provide for and clarify the MALTA DIGITAL INNOVATION AUTHORITY powers of the Authority for the better carrying out of any of the provisions of this Act; (
- h)amend, repeal, add to and, or vary any of the Schedules to the Act and any regulations made thereunder; (
- i)establish rules and empower the Authority to prescribe rules and to achieve the purposes of the Act, and the effective administration of the Act and, or any other law which the Authority is empowered to administer or enforce or any European Union and, or international legislation having effect in Malta; (
- j)establish rules and empower the Authority to prescribe rules for the mutual recognition of recognitions issued by other national, foreign or international authorities or bodies; (
- k)issue further guidance and empower the Authority to issue further guidance regarding the form, accessibility and minimum contents of information that shall be made available to users of innovative technology; (
- l)define and empower the Authority to define different levels of recognition that may be obtained in relation to innovative technology; (
- m)technology further regulate recognitions of innovative (
- n)further regulate the recognition of innovative technology service providers, including the level of independence and other qualities, if any, that are required for the carrying out of their functions and the definition of such terms; (
- o)define the criteria for determining whether the systems and security access protocols of applicants or recognition holders, as applicable, meet or are maintained to the appropriate international standards that may be established from time to time; (
- p)prescribe rules for the notification of any activities in or from Malta, or relating to innovative technology which are accessible through the website of the Authority, including when the innovative technology already has the recognition in another country; (
- q)establish the circumstances and empower the Authority to establish the circumstances in which any person involved in connection with a recognition holder, including MALTA DIGITAL INNOVATION AUTHORITY any service provider is obliged to communicate information to the Authority, prescribe regulations governing the disclosure of information by service providers and establish supervisory and disciplinary procedures for service providers in respect of their duties; (
- r)extend any provisions of the Act, including but not limited to, the right to an effective judicial remedy to any form of innovative technology; (
- s)by regulations made under the Act amend any Schedule made under the Act; (
- t)clarify by means of guidelines any definition in sub-article
- u)empower and designate the Authority as a competent authority and, or supervisory authority and, or market surveillance authority in relation to innovative technology, data or any other area, as may be prescribed by the Minister; (
- v)grant to the Authority the power to issue recognitions, create processes and structures, facilitate and generate data sharing by natural or legal persons and the public sector; and (
- w)prescribe fees in consultation with the Minister responsible for finance. The Minister may direct or authorise the Authority to establish all necessary details to meet any of the above requirements and conditions by way of guidelines and other binding regulatory instruments to be issued by the Authority under article 6 which shall be ancillary to or independent of any regulations made under the above powers.
- In this Act and in any regulations made thereunder, if there is any conflict between the English and Maltese texts, the English text shall prevail. Substituted by: XIX.2024.
- FIRST SCHEDULE (article 2) Innovative Technology (a) artificial intelligence; (b) "distributed ledger technology" and "decentralised ledger technology (DLT)"; (c) internet of things. SECOND SCHEDULE [Article 5