Key legal aspects of implementing digital therapeutics (DTx) in Romania

For software manufacturers that are interacting with the healthcare system, it is important to know if the software developed qualifies as a medical device. Software that is considered a medical device can be placed on the market or put into service only if it complies with the rules applicable to medical devices.  

However, not all software used within healthcare is qualified as a medical device. This is why understanding the rules on the qualification of medical devices is important.  

As Romania is a Member State of the European Union, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“MDR”) is directly applicable in Romania.  

The Romanian Government adopted, by Emergency Ordinance no. 46/2021 (“GEO 46/2021”), the measures establishing a framework for the implementation of the MDR.  

Under the MDR, “medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: 

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, 
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, 
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, 
• and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. 

The following products shall also be deemed to be medical devices: 

• devices for the control or support of conception; 
• products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.” 

Therefore, it can be observed that software must have a medical purpose on its own to be qualified as a medical device software. To this aim, the intended purpose as described by the manufacturer of the software is relevant.  

If the software does not fall within the definition of medical devices, it might be intended as an accessory for a medical device or an in vitro diagnostic medical device. In such cases, the respective software still falls under the scope of MDR or, respectively, the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“IVDR”).  

According to the MDR, an “‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);”.  

Under the IVDR, also directly applicable in Romania, “in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: 

1. concerning a physiological or pathological process or state; 
2. concerning congenital physical or mental impairments; 
3. concerning the predisposition to a medical condition or a disease;
4. to determine the safety and compatibility with potential recipients; 
5. to predict treatment response or reactions; 
6. to define or monitoring therapeutic measures.” 

There are also implementing and classification rules in the MDR that indicate certain software that is considered a medical device. As such, it is considered a medical device:  

• the software that drives a device or influences the use of a device 
• the software that is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes 
• the software intended to monitor physiological processes.  

For cases where it is hard to draw a line between mere software and medical devices, there is a Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR („Software Qualification Guidelines“), endorsed by the Medical Device Coordination Group (MDCG) within the European Union, but which is not legally binding. However, it sets out orientations and examples to help qualify the software as a medical device. 

For example, according to the Software Qualification Guidelines:  

• are not medical devices in themselves: hospital information systems (that support the process of patient management); information systems that are intended only to transfer, store, convert, format, archive data; communication systems that are normally based on software for general purposes; Image Management System only used for viewing, archiving and transmitting images; Software intended for archiving patient results or for transferring results obtained from in vitro diagnostic medical devices from the home environment to the healthcare provider;  
• are medical devices: decision support software; software module generating alarms based on the monitoring and analysis of patient specific physiological parameters; telesurgery systems; modules that are intended to influence the surgery procedure, modules that are intended to monitor the medical performance of medical devices; modules whose intended purpose is to assess the criticality of tests required and to perform automatic reprioritisation of the order based on patient data.  

Other examples of qualification of software as a medical device can be found in the  Manual on Borderline and Classification in the Community Regulatory Framework For Medical Devices (europa.eu). 

According to the Software Qualification Guidelines, the following decision steps should be taken for qualification of software as a medical device:  

1. Assess if the product is a software. 
2. Assess if the product is an MDR Annex XVI device (products without an intended medical purpose that are listed in Annex XVI), or an accessory for a medical device, or a software driving or influencing the use of a medical device. If affirmative, then it must be considered as part of that device in its regulatory process or independently if it is an accessory, and the MDR or the IVDR is applicable. If it is not, step 3 must be followed.  
3. Assess if the software does perform an action on data, or performs an action beyond storage, archival, communication, simple search, lossless compression (i.e., using a compression procedure that allows the exact reconstruction of the original data) then it may be a medical device software. If not, then the MDR or the IVDR is not applicable. If yes, step 4 must be followed. 
4. Assess if the action is for the benefit of individual patients. If not, then the MDR or the IVDR is not applicable. If yes, step 5 must be followed. 
5. Assess if the software is a medical device software according to the Software Qualification Guidelines. If yes, then the MDR or the IVDR is applicable. 

The primary legislation in Romania regulating the processing of personal data is the EU General Data Protection Regulation 2016/679 (“GDPR”) and Law 190/2018 regarding the measures for implementation of GDPR. In addition, the Romanian Data Protection Authority for Personal Data Processing (“RDPA”) may issue secondary legislation, for instance, RDPA Decision no. 174/2018 on data processing operations which require mandatory data privacy impact assessments. Special data privacy requirements may also be found in the healthcare regulations.  

In what regards DTx, processing of health data is particularly noteworthy. Such data has a special regime under the GDPR (is deemed a special categories of data) and generally triggers more complex compliance requirements. 

Below we emphasize the most significant aspects that should be considered to ensure the data privacy compliance: 

1. clearly establish the type of personal data that are being processed. Special attention should be given in relation to which data qualifies as “health data” (for instance, determine in which cases lifestyle data should be treated as health data); 
2. establish the right legal basis for processing - note that GDPR provides limited cases when health data may be processed (usually, medical software/app process health data based on the explicit consent of the patient); 
3. determine specifically defined purposes of the data processing, to mitigate the risks of data misuse; In case of an app has different functionalities, the explicit consent should be obtained for each of them; 
4. the processing should concern the general principles under GDPR (e.g., processing concerns only personal data that is adequate, relevant and limited to what is necessary in relation to the processing purpose); 
5. provide a prior information on the data processing to the data subjects, which includes the minimum information required under GDPR (e.g., via data privacy notices); 
6. implement appropriate technical and organisational measures for ensuring the adequate security of data (e.g., proper anonymisation measures and other security measures, including privacy by design and data minimisation); 
7. put in place data privacy policies applicable at the company level and provide specific training for the personnel that has attributions in handling personal data;  
8. establish specific data storage periods, or at least specific criteria used to determine such storage period; 
9. prepare data privacy clauses / data processing agreement to be used in contractual relationship with business partners (service providers, suppliers, etc.); 
10. keep records of the data processing activities and related compliance measures;  
11. conduct periodical audits to ensure that data privacy measures maintain their relevancy; 
12. ensure that any transfer of personal data outside EU is properly backed up (e.g., existence of an adequacy decision, standard contractual clauses etc.) 
13. assess whether appointing a data processing officer is mandatory under GDPR; 

In addition to the above requirements which result from GDPR implementation, the national law provides additional specific requirements for processing of personal data (note that the below may not be a complete list of requirements, thus a further analysis would be required based on the processing specifics), for instance: 

1. obtain the explicit consent of the data subject in case the health data processing is carried out for automated decision-making and profiling purposes; by way of exception, the explicit consent is not required when processing is carried out under the express provisions of law; 
2. carry out a protection impact assessment in case the health data processing is done on a large scale;  
3. obtain the explicit consent for transfer to third party of information regarding the patient's condition, results of investigations, diagnosis, prognosis, treatment (unless the law explicitly required it). 

When placing a medical software or DTx product on the market in Romania, companies need to consider and comply with several additional legal requirements, including: 

• Technical Standards: Companies must ensure compliance with relevant technical standards and regulations applicable to the respective product. This may involve, for example, conformity with ISO 13485 (Quality Management Systems for Medical Devices) and other relevant standards. 
• Labeling and Instructions for Use: Depending on the product’s classification, companies need to follow the legal requirements on labeling and instructions for use. For example, if the product qualifies as medical device, there is a complex set of requirements that aim to ensure that companies provide accurate and comprehensive information about the software's purpose, limitations, and proper usage, in Romanian language. 
• Reimbursement Requirements: If seeking reimbursement from public health funds or private insurers in Romania, companies must understand the specific reimbursement criteria and documentation requirements (see further details in Part 3 – Payment). 
• Advertising and Consumer Protection: Other key legal aspects worth mentioning include: (i) consumer protection laws (setting out general rules for advertising and protection against misleading, unfair, or aggressive practices); (ii) unfair commercial practices (Law no. 363/2007 implementing Directive 2005/29/EC prohibits unfair commercial practices, including misleading advertising, false information, and aggressive sales techniques); and (iii) comparative advertising. Additional requirements may apply depending on the product’s classification. For example, if the product qualifies as medical device, there is a complex set of requirements on advertising of medical devices set out by GEO 46/2021. These measures regulate advertising for medical devices, distinguishing between advertising targeted at the general public and advertising aimed at healthcare professionals, establishing criteria for responsible and accurate advertising, prohibiting misleading claims, and requiring the submission and approval of advertising materials by the competent authority, as the case may be.  

According to GO 46/2021, advertising for medical devices can be made to the general public or to persons qualified to recommend or distribute medical devices.  

Advertising of a medical device must: 

• encourage the rational use of the medical device by presenting it objectively and without exaggerating its properties; 
• not be misleading; 
• contain accurate, up-to-date, verifiable and sufficiently comprehensive information to enable, where appropriate, the general public to understand the use of the medical device and healthcare professionals to appreciate the characteristics and performance of the medical device. 

GO 46/2021 further provides that:  

• It is prohibited to advertise a medical device for which clinical evidence does not support the achievement of its intended purpose. 
• All information contained in advertising material for a medical device must be consistent with the information contained in the instructions/manual for use of the product. 
• Advertising to the general public of medical devices for special purposes, which are used only on medical advice, is prohibited. 
• Advertising to the general public is permitted only for those medical devices which, by purpose, are intended to be used without the intervention of qualified medical personnel for the purpose of diagnosis, recommendation or monitoring of treatment, whereby the advice of pharmacists is sufficient if necessary. 

Any advertising material aimed at the general public must: 

1. be so designed that it is clear that the message is of an advertising nature and that the product is clearly identified as a medical device; 
2. include at least the following information: the name of the medical device, a clear definition of the intended purpose of use, information necessary for the proper use of the medical device and an express, legible invitation to read carefully the instructions in the user manual of the product. 

Advertising of medical devices to the general public must not contain any material which: 

1. suggests the impression that medical consultation or surgery is not necessary; 
2. suggests that the diagnosis, the result of the determination, established with a medical device is guaranteed, cannot be accompanied by errors or that the effect of treatment with a medical device is guaranteed, is not accompanied by adverse reactions or that the effect is better than or equivalent to that of another treatment with another medical device or medicine; 
3. suggests that the subject’s state of health may be affected if the medical device is not used; 
4. is directed exclusively at children; 
5. refers to a recommendation by scientists, health professionals or persons who are not in these categories but whose celebrity may encourage the use of the medical device; 
6. suggests that the medical device is a cosmetic or relaxation product or other consumer product; 
7. suggests that the safety or effectiveness of the medical device is due to the fact that it is natural; 
8. may, by a detailed description or representation of a case, lead to a misdiagnosis of self; 
9. gives, in inappropriate, alarming or misleading terms, assurances of cure through the use of the medical device in question; 
10. uses, in inappropriate, alarming or misleading terms, visual representations of changes in the human body caused by disease or injury or by actions of medical devices on the human body or part of it. 

Advertising for medical devices intended for healthcare professionals must contain the following information: 

• the mention that it is intended exclusively for health professionals; 
• the name of the medical device, the name of the manufacturer or its representative; 
• the clear definition of the purpose for use set by the manufacturer, of the characteristics and performances of the medical device, for which the advertisement is made; 
• medical device class; 
• the essential information for the use of the medical device; 
• the express invitation to carefully read the instructions/user manual of the product and those on the label intended for health professionals. 

The documentation on the advertising of a medical device to the general public must be submitted by the manufacturer, importer or distributor of the medical device to the ANMDMR for approval and disseminated only after obtaining the advertising visa. 

The ANMDMR is the competent authority for the assessment, notification and approval of advertising material, except for those intended for health professionals when they do not belong to the category of medical devices with a high health risk for the population. 

The advertising aimed at healthcare professionals of a medical device that belongs to the category of medical devices presenting a high risk, must be notified by the manufacturer, importer or distributor of the medical device, to the ANMDMR, in advance, as a matter of urgency.  

In order to issue the advertising visa, the applicant: 

• submits to the ANMDMR the application for the issue of the advertising approval, to which proof of payment of the evaluation fee shall be attached; 
• keeps available or send to the ANMDMR, upon request, a sample of all advertising material produced on his own initiative, together with a statement indicating the persons to whom the medical device is addressed, the method of disclosure and the date of first disclosure; 
• ensures that advertising materials developed for its medical devices comply with the provisions on advertising; 
• provides the ANMDMR with any other information and assistance necessary to fulfil its responsibilities. 

Failure to comply with the provisions on advertising of medical devices is considered a misdemeanor.  

Advertising of medical devices to health professionals can include: 

• visits by medical representatives to persons qualified to recommend medical devices; 
• provision of samples; 
• sponsorship of promotional meetings attended by persons qualified to recommend or distribute medical devices; 
• sponsorship of scientific congresses attended by persons qualified to recommend or distribute medical devices and, in particular, payment of the travel and accommodation expenses incurred. 

The legal framework does not provide more guidance on the use of economic benefits/incentives as promotional tool. Currently there is a draft Order approving the Methodological Norms regarding advertising for medical devices, but it hasn’t entered into force yet. It provides for relevant rules on the advertising of medical devices, including conditions in which advertising is allowed.  

Where the law in force does not set all parameters of a particular relationship, the relevant market practice should be observed. In this respect, the main codes applicable for medical devices are the MedTech Code (on a European level) and the RASCI Code (on a national level).  

The RASCI Code should be taken into account as practice market and as guidelines for implementing the legislation in force at a national level. Amongst others, it provides for rules in connection with: 

• the transmission of promotional objects, informational/educational items and items of medical utility to healthcare professionals; 
• organizing events and hospitality offered to healthcare professionals for such events; 
• sponsorship/donations/grants (in cash or in kind or otherwise) and/or free-leases to/by public institutions, organizations or associations that are comprised of healthcare professionals and/or that provide healthcare or conduct research 
• sponsorship of healthcare professionals; 
• distribution of samples. 

Manufacturers should bear in mind that some promotional activities may be considered sponsorship/donations/grants, which are subject to particular rules under Romanian legislation, such as: 

• requirement to notify all sponsorship activities, as well as any other expenses incurred for doctors, nurses, professional organisations, patients' organisations and any other type of organisation working in the field of health, to ANMDMR) (Law 95/2006 and Order 874/2015 approving the forms for the declaration of sponsorship activities in the field of medical devices and medical supplies).  
• donations of medical devices should be based on medical needs and should receive in advance a donation notice issued by ANMDMR. Only medical devices that bear the CE conformity marking and have undergone pre-market conformity assessment according to the European rules on medical devices are accepted as donations. (2011 Norms on donations of medicines, medical supplies, medical devices, vaccines, serums and related consumables). 
• only medical devices that have all the accessories necessary to enable them to be used for their intended purpose as stated by the manufacturer, are in working order and do not deviate from the applicable functional performance and safety requirements will be accepted as donations (2011 Norms on donations of medicines, medical supplies, medical devices, vaccines, serums and related consumables). 
• the beneficiary of a donation must be a health facility with a closed-circuit pharmacy, a social assistance unit or a non-governmental organization that employs authorized medical staff - doctor or pharmacist - according to the legislation in force (2011 Norms on donations of medicines, medical supplies, medical devices, vaccines, serums and related consumables). 
• sponsorship/ donations/ grants/ free-leases that support healthcare or research may be offered to public institutions or organizations or associations comprised of healthcare professionals (not to individual healthcare professionals) if they are documented and kept on record by the donor/grantor; do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific products; are specifically based on a request from the respective organization/association/institution (RASCI Code). 
• articles used strictly for medical purposes may only be supplied to public institutions (not to individual healthcare professionals) and should cover gaps caused by underfunding of the health system (RASCI Code).  

Furthermore, the legislation in force provides for certain limitations in the interactions between authorities/hospitals/institutions and suppliers. According to Law 95/2006:  

• Companies that own private ambulance services cannot give donations or sponsorships to public pre-hospital emergency services (Art. 106(2)) 
• Doctors and nurses in charge of emergency units may not be sponsored and/or financed, directly or indirectly, for participation in conferences, congresses and other types of events, by companies that market pharmaceutical products and/or medical supplies or companies representing their interests, nor by medical equipment companies. In special, well-justified circumstances, exceptions may be obtained only with the approval of the Ministry of Health. (Art. 108(5)) 
• The General Manager and the members of the Board of Directors of the county and Bucharest-Ilfov Ambulance Services, as well as the SMURD Chief Medical Practitioner, may not receive sponsorship and/or funding, directly or indirectly, for participation in conferences, congresses and other types of events, from companies that market pharmaceutical products and/or medical supplies or companies representing their interests, medical equipment companies and companies marketing ambulances and other emergency vehicles or their representatives. In special, well-justified circumstances, exceptions may be obtained only with the approval of the Minister of Health or the Minister for Internal Affairs, on a case-by-case basis. (Art. 118(4) and Art. 122(3)).  

Providers of medical devices can partner with various entities on a contractual basis.  

Where the law does not prohibit certain relationships, it can be construed that these are permitted. 

The law provides for cases where the interaction of medical devices manufacturers is prohibited. These cases should be taken into account. For example, in case of public procurement won by the company, the successful tenderer with whom the contracting authority has concluded the public procurement contract shall not be entitled to engage or enter into any other arrangements for the provision of services, directly or indirectly, for the purpose of performing the public procurement contract, with natural or legal persons who have been involved in the process of verifying/evaluating requests to participate/tenders submitted in the framework of an award procedure or employees/former employees of the contracting authority or of the procurement service provider involved in the award procedure with whom the contracting authority/procurement service provider involved in the award procedure has terminated contractual relations subsequent to the award of the procurement contract, for a period of at least 12 months after the conclusion of the contract, under penalty of termination or automatic termination of the contract in question. 

Also, where the special law does not regulate, the general rules of civil law will be applicable. 

Depending on the type of services, contracts may need to fulfill certain formal requirements (written form, notarized form etc). 

In all cases, manufacturers should pay attention to liability sharing provisions. In some cases, manufacturers remain liable under the law, even if the contract provides otherwise. 

Manufacturers can trade their devices directly to end users or through distributors.  

Note that, under the MDR, where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. 

According to the MD Methodological Norms, the activities of import, distribution, installation and maintenance of medical devices must be authorized by ANMDMR.  

The legislation in force does not provide for particular ways to distribute medical devices.  

Generally, contracts for the purchase of medical equipment and appliances in the medical devices category are awarded, as competitive open tendering procedures.  

Public procurement is meticulously regulated in Romania mainly by Law no. 98/2016 on public procurement and by Law no. 99/2016 on sectoral procurement.  

Some of the medical equipment/devices used by public hospitals are entrusted by companies through contracts for donation/free use/sponsorship agreements. As mentioned in section 3 b) above, sponsorship/donations/grants are subject to particular rules under Romanian legislation.  

Also, it should be noted that the Competition Council issued in 2020 a Report on healthcare market services and related activities and related activities, in which it described several competition law concerns regarding the procurement of medical devices and recommended some ways forward.  

For example, it recommended the Ministry of Health to regulate the modalities of entrusting medical equipment/devices through free rental agreements, deeds of donation or deeds of free of charge/sponsoring or similar forms to public hospitals for the purposes of applying clear criteria for the selection of the supplier and limiting the period of entrustment.  

On the same matter, the Competition Council also issued a Study report on the lock-in effect in sensitive sectors in procurement public procurement, it and medical equipment/devices. It aimed to analyse the long-term dependence of contracting authorities on a particular supplier/distributor. The dependency of contracting authorities can be defined as a obligation of contracting authorities to use the services of a single supplier for the purchase of products/services in addition to those they already own. 

The analysis of the captive effect focused on two economic sectors likely to be affected more affected by this phenomenon: the IT sector (in particular the case of specific software applications, developed on demand) and the medical equipment/devices and related services sector (consumables, spare parts and maintenance services). 

Therefore, manufacturers should consider competition rules, which play an important rule on the distribution of medical devices to contracting authorities.   

Also, it should be noted that there is the possibility in certain cases that certain medical devices to enter the national reimbursement program in order for people to benefit from this measure.  

When exploring options to generate revenue from a DTx product in Romania, there are various avenues to consider: 

• Targeting Healthcare Organizations: Depending on the product’s classification, companies may decide to market the DTx product directly to healthcare organizations (e.g., hospitals, clinics, or medical practices). It is important to establish clear contractual agreements with healthcare organizations to define important aspects, such as the terms of access, usage, and payment. 
• Employers: Companies may be interested in offering the DTx product as part of employee benefits programs to promote employee health and well-being. Similar to the above, setting up the contractual agreements with employers is an important step in the process that needs to be carefully considered. 
• Collaboration with Insurance Companies: Private insurance companies in Romania may potentially cover the DTx product as part of their health insurance plans. However, reimbursement policies and requirements can vary among different insurers. Collaboration with insurance companies would involve negotiations and agreements, ensuring compliance with reimbursement criteria and documentation requirements. 
• Public Health Insurance Reimbursement: In Romania, the National Health Insurance House (CNAS) manages the public health insurance system. Depending on the product’s classification, there might be opportunities for reimbursement by public health funds; however, compliance with reimbursement criteria and documentation requirements would be necessary. For context, certain medical devices are reimbursed in the national health insurance system, at a value established by the competent authorities. CNAS and the other public health insurance houses in its subordination cover the reimbursed value, by providing the reimbursement amounts to the pharmacies releasing the reimbursed medicinal products and/or medical devices, based on special supply agreements. 

When exploring monetization through sales to private parties or payors in Romania, the following considerations should be taken into account: 

• Pricing Structure: When it comes to pricing, private payers provide more flexibility compared to the public healthcare system. Companies should create pricing models that take into account the affordability and requirements of private customers. During the contract negotiation phase, it is important to consider different factors, including competition regulations and consumer protection laws, to ensure fair pricing practices and transparency. 
• Market Segmentation: To effectively reach and engage potential customers, companies may want to focus on specific groups within the private market who would benefit most from the DTx product. This can be based on factors like health conditions or lifestyle preferences. When tailoring marketing strategies and product positioning for these target segments, it is essential to ensure compliance with applicable laws, such as data privacy and advertising regulations. 
• Value Proposition: Companies will want to clearly communicate the unique value that the DTx product offers to private payers, emphasizing the benefits, outcomes, and potential cost savings associated with using the product. When communicating the value proposition of the DTx product to private payers, it is important to ensure compliance with advertising regulations, e.g., to ensure that false or misleading claims are avoided. 

When exploring monetization through sales to public entities or the public healthcare system in Romania, companies should focus on the following: (i) understanding the Romanian legal framework on reimbursement; and (ii) understanding the contractual agreements concluded with public entities (the contracts are generally standard and non-negotiable and thus, companies must pay particular attention to the terms and conditions of reimbursement, usage, and other relevant aspects). 

As context, it is worth noting that in the case of medical devices, their prices are not strictly regulated by law. However, the reimbursement value of medical devices is approved by the Ministry of Health and/or the CNAS. Patients insured under the national health insurance system can obtain the respective medical devices from pharmacies that have reimbursement agreements with health insurance houses. They may receive them either free of charge or by making a co-payment, based on the value established by the Ministry of Health and/or the CNAS. CNAS and other public health insurance houses subordinate to it cover the reimbursed value by providing reimbursement amounts to the pharmacies that distribute the reimbursed medical devices, pursuant to special supply agreements. 

When it comes to potential pitfalls, these may include delays in contract negotiations, changes in reimbursement policies, or administrative hurdles. Maintaining open communication, staying updated on regulatory changes, and seeking legal guidance can help mitigate these risks and ensure a smooth monetization process. 

The status quo in Romania does not include a reimbursement scheme specifically designed for DTx products or prescribed apps. We are not aware of any news or indications of such a mechanism being implemented in the near future.