Welcome to the autumn edition of our Healthcare Sector Update series. In this interactive magazine, we feature our most popular insights from the past month. We hope you find it informative.
First up, in the above video, Health & Prosecutions partners Brian Horkan and Fiona McNulty provide an insightful overview of the 2024 Mental Health Bill, highlighting its shift towards a more person-centered, rights-based approach. In this issue, we also examine a selection of topics and trends impacting our clients including:
• Calculating Damages for Multiple Injuries Under the Personal Injuries Guidelines
• New Legislation Tightens Regulations for Ireland’s Nursing Home Sector
• Patient Safety Act Commences Introducing Mandatory Open Disclosure
• Compensation Payments in Catastrophic Injury Claims
Please get in touch with a member of our Healthcare Sector team if you wish to discuss these issues or any other matters impacting your organisation.
Key Contacts
Robert Dickson Partner, Corporate | Healthcare Sector Lead rdickson@mhc.ie
Kevin Power Partner, Head of Medical Law kpower@mhc.ie
Catherine Allen Partner, Head of Public, Regulatory & Investigations callen@mhc.ie
Brian Horkan Partner, Head of Health & Prosecutions bhorkan@mhc.ie
Contact our Healthcare Sector team
Calculating Damages for Multiple Injuries Under the Personal Injuries Guidelines
Kevin Power Partner, Head of Medical Law kpower@mhc.ie
Calculating general damages under Ireland's Personal Injuries Guidelines is not straightforward when multiple injuries are involved, which is often the case in medical negligence cases. Courts must balance compensating for each injury while ensuring the total award remains fair and proportionate. A "dominant injury" is identified and an "uplift" is applied to account for additional injuries. Recent court decisions highlight the diverse methods of calculation of general damages. Our Medical Law team explores these approaches and offers insights into how damages are calculated.
The Personal Injuries Guidelines set out ranges of monetary sums or damages for compensating certain categories of injury. The process of determining the level of compensation is usually simple where just one injury is sustained. However, many cases can involve multiple injuries. This is particularly true in medical negligence claims. The cornerstone of the Guidelines is to ensure plaintiffs are ‘fairly and justly compensated’ by an award which is ‘proportionate and just’.
Aislinn O'Shea Senior Associate, Medical Law aoshea@mhc.ie
Kate Moloney Associate, Medical Law
kmaloney@mhc.ie
Computing the ‘uplift’
When assessing multiple injuries, it is necessary to identify the “dominant injury” and its suitable level of damages under the Guidelines. Once the dominant injury is determined, the other “nondominant” injuries are considered. The Court will then apply an “uplift” to the value of the dominant injury to reflect the impact of the other injuries sustained by the claimant.
Recent High Court and Court of Appeal judgments have illustrated that this is not a settled science.
Mr Justice Coffey in a case entitled Lipinski v Whelan quantified damages for the dominant injury. The judge then applied a further cumulative uplift regarding other injuries sustained, without providing a breakdown of the level of damages allowed for each of the non-dominant injuries.
In a separate case, McHugh v Ferol, an overall discount was applied to the total value of the nondominant injuries to reflect the temporal overlap of the injuries. In this instance, the Court did provide a breakdown of the level of damages allowed for each of the non-dominant injuries. More recently, in O’Sullivan v Ryan, varied discounts were applied from the outset to the level of damages for each of the non-dominant injuries to reflect that some injuries shared the same temporal period, while the effects of others lasted beyond it.
Other matters to bear in mind when computing damages for multiple injuries
‘Reality check’
The Court of Appeal in Zaganczyk v John Pettit Wexford Unlimited Company emphasised that there should be a comparison of the overall award to other individual categories set out in the Personal Injuries Guidelines. If the total award exceeds the value of an award for a more serious injury, that should act as a “reality check” and trigger a recalculation to ensure the award is proportionate. The Court of Appeal reduced the total general damages from €90,000 to €60,000 for a posttraumatic stress disorder (PTSD) dominant injury. It noted that severe neck injuries, which may require spinal fusion and involve significant permanent disability, are valued between €70,000 and €100,000 under the Personal Injuries Guidelines, and this acted as a reality check.
Where the cumulative effect of the injuries is worse than an individual injury
In Keogh v Byrne, the High Court emphasised that applying an uplift is secondary to the trial judge's duty to "fairly and justly" compensate the plaintiff for all injuries. The award must remain "just and proportionate."
This requires the judge to step back from assessing individual injuries and their assigned values to holistically evaluate the cumulative impact on the plaintiff. In certain cases, the combined effect of multiple injuries may be more severe than the sum of each injury alone. The example provided is where a plaintiff suffers injuries to both eyes resulting in total blindness.
Comparison of different methods of computing damages for multiple injuries
From these judgments, it is apparent that there is not one simple formula that can be used for the calculation of damages of multiple injuries. Generally, the dominant injury is identified, and an uplift is applied for the non-dominant injuries. The Courts have used different methods when calculating an uplift:
• By making a deduction from the damages that are tallied for the non-dominant injuries, or
• By making an initial deduction to each of the non-dominant injuries
In these scenarios, the deductions can be expressed as a percentage or by a specified sum. Set out and available to download below is a helpful quick reference guide, which provides a comparison of some of the methods used by the Courts.
Conclusion
Although different methods of adjustment exist, the Courts have noted that they hold little practical significance, as long as the final award of general damages is calibrated to ensure overall fairness and proportionality in compensating a person who has sustained multiple injuries. There may be additional methods employed by the Courts, particularly in cases where multiple dominant injuries exist, and it is difficult to determine which is the most significant — a common scenario in medical negligence claims.
In addition, the Guidelines do not cover all complex injuries, such as damage to organs or vessels, frequently encountered in treatment for underlying medical conditions or injuries. It remains to be seen how the Courts will address multiple injuries in future medical negligence cases, and we await further developments with interest.
For more information and expert advice on defending claims, contact a member of our Medical Law team.
New Legislation Tightens Regulations for Ireland’s Nursing Home Sector
New legislation is altering the regulatory landscape in the nursing home sector. In this article, we break down the key amendments to the Health Act 2007 and the Nursing Home Support Scheme, outlining crucial compliance measures that nursing home providers must now navigate. With enhanced oversight powers for HIQA and adjustments to the Fair Deal scheme, these changes are set to impact day-to-day operations for nursing home operators. Our Healthcare team explains how the new requirements will affect your business and how you can ensure your organisation stays ahead of evolving regulations.
The evolving regulation of the nursing home sector takes a step forward with the introduction of the new Health (Miscellaneous Provisions) (No. 2) Act 2024. This legislation, which came into force in September 2024, amends the Health Act 2007 as well as the Nursing Home Support Scheme Act 2009. In this article, we review the 2024 Act and outline the biggest changes that nursing home providers should be aware of.
Changes to the Health Act 2007
The 2024 Act introduces additional powers for the Chief Inspector of Health Information and Quality Authority (HIQA). In some instances, it also extends the scope of her powers as follows:
1. Power to request and collect additional information on nursing homes
Under a new Section 65A and 65B of the Health Act 2007, the Chief Inspector of HIQA now has the authority to request additional information from nursing home providers if she reasonably believes that previously submitted information is incomplete. This additional information can then be used to fulfil the Chief Inspector's regulatory functions. In addition, the new legislation provides that where the Chief Inspector makes a request for additional information, the nursing home provider is required to comply with it and a nursing home provider shall not submit information which it knows, or should reasonably know, to be false or misleading.
Under new Section 101B of the Health Act 2007, the Minister for Health has the power to introduce new regulations determining:
• The types of information to be provided by nursing home operators. This includes details of the number of beds, the types of services offered, and charges imposed on residents
• The information to be provided by the Chief Inspector to the Minister for Health, HIQA and the Health Service Executive (HSE)
• The frequency at which information is required to be submitted
• The public bodies to which the information is to be provided, and
• The information which can be published
2. Power to share and publish key operational data on nursing homes
Under the new Section 65A of the Health Act 2007, there is also an obligation on the Chief Inspector to establish and maintain a record of the information provided to it by the nursing home providers. In addition, the Chief Inspector can now also share this information with the Minister for Health, HIQA and the HSE and specified public bodies. However, the data must be anonymised, or certain details excluded, to ensure that no individual can be identified from the shared information.
The Chief Inspector can publish certain information about the nursing home for the purpose of informing residents and prospective residents, and/ or their family members, regarding decisions which they might wish to make in connection with that nursing home
3. Power to issue compliance notices to nursing home providers
The most notable change is under the new Section 78(A). This provision now allows HIQA to issue compliance notices on nursing home providers where the Chief Inspector is satisfied the nursing home has contravened or is contravening, the Health Act 2007. To date the Chief Inspector was limited to applying conditions/restrictions or, in extreme cases, cancelling a registration.
Now, however, she can consider compliance notices as an enforcement tool in the same way as other regulated sectors.
The notice shall specify:
• The circumstances that constitute the breach
• What the nursing home provider is required to do, or refrain from doing, to comply with the legislation, and
• How to appeal against the notice
A nursing home provider that has been served a compliance notice can appeal the notice to the District Court. An appeal must be lodged with the Court no later than 14 days after the notice was served. The District Court may then, having considered the grounds for the appeal, confirm the compliance notice in whole or in part, with or without amendment of the notice, or direct the Chief Inspector to withdraw the compliance notice. If a nursing home provider fails to comply with the notice, it shall be guilty of an offence and shall be liable:
• On summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months or both, or
• On conviction on indictment, to a fine not exceeding €70,000 or imprisonment for a term not exceeding 2 years or both
4. Increased scope for investigation – power
to investigate unregistered premises
Under the new Section 73A, the power to investigate breaches of the standards of nursing home providers has been expanded. It now includes investigations of unregistered premises, even if that premise is not breaching any of the standards. The Chief Inspector has the power to obtain a warrant from the District Court to search a premises where she has reasonable grounds to believe it is an unregistered nursing home.
5. Changes to the timelines for the current enforcement process
The 2024 Act provides that the time period for responding to a notice of any decision of the Chief Inspector or appealing a decision to the District Court regarding registration, e.g. to cancel or refuse registration, has been reduced from 28 days to 14 days.
Changes to the Nursing Homes Support Scheme Act 2009 (Fair Deal Scheme)
An amendment to the Fair Deal Scheme was introduced through the Nursing Homes Support Scheme (Amendment) Act 2021. The amendment extended the three-year cap that applies to the applicant's principal private residence to family farms and business assets, where a family successor is appointed. This family successor was required to:
• Continue to run the farm or business for at least a period of six years, and
• Have at least consistently applied to running the family asset for at least three of the last five years
While the amendment was welcomed, some individuals without close relatives are unable to benefit from this relief as they do not have anyone who meets the eligibility criteria for a family successor. The New Act addresses this issue and the safeguards for family farms and businesses now apply to the extended family, including cousins, great-nieces, great-nephews and greatgrandchildren.
It has long been acknowledged that the Fair Deal Scheme requires a review and we hope to see further changes.
Comment
The amendments to the Health Act 2007 enhance the existing regulatory framework for nursing homes, strengthening the Chief Inspector’s powers, and improving current provisions to ensure a more robust system of regulation. The changes to the Fair Deal Scheme are of central importance for those individuals who do not have immediate family relatives.
If you have any questions regarding the 2004 Act, or how the newly introduced changes will materially impact your business operations, please contact a member of our Healthcare team.
Patient Safety Act Commences
Introducing Mandatory Open Disclosure
Kevin Power Partner, Head of Medical Law
kpower@mhc.ie
Sarah Smyth Associate, Medical Law
ssmyth@mhc.ie
Katie
McAuliffe Senior Associate, Medical Law
kmcauliffe@mhc.ie
The Minister for Health has recently confirmed the commencement of the Patient Safety Act. Our Medical Law team examines the scope and the likely impact of this landmark legislation, which implements mandatory open disclosure for the first time in Ireland.
The commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides for mandatory – as opposed to voluntary – open disclosure. This marks a major development for the Irish healthcare sector.
Healthcare practitioners are now required under law to make open disclosure regarding a list of patient safety incidents which may occur during the provision of health services. We reviewed the key features of this legislation in a previous article
In a separate update, we also discussed the launch of the National Open Disclosure Framework in October 2023 as well as the various steps being implemented to prepare for commencement of the Act.
On World Patient Safety Day, 17 September 2024, the Minister for Health announced that all preparatory steps had been completed.
Private health services to be monitored by HIQA
It was also confirmed that the Minister had approved amendments to HIQA’s National Standards for Safer Better Care. The amendments mainly address the expansion of HIQA’s remit to monitor certain private health services and private hospitals. This will enable HIQA to set standards for the operation of these services, to monitor compliance and to undertake inspections and investigations, as required.
Cultural shift
In a press release published on commencement date, 26 September 2024, the Minister stated as follows:
“[The Act] will serve an important role in progressing a cultural change in our health service whereby, together, we create space for openness and transparency in our everyday actions. Ireland has made another great stride forward in our suite of patient safety legislation and this will signal a new era for the health service.” 1
What next?
The majority of the Act has been commenced. A further technical amendment is set to be made to Section 68. This will provide the Chief Inspector within HIQA with a discretionary power to carry out a review of certain serious patient safety incidents which may occur in a nursing home. This Section is expected to commence shortly.
Interestingly, Section 80 mandates that a full review of the operation of the Act will take place two years following its commencement date.
1 “Minister for Health announces commencement of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023”, 26 September 2024
Comment
This is an important piece of legislation which will pave the way to ensuring that patients have timely access to information. The aim is that the mandatory open disclosure provisions in the Act will contribute to embedding a culture whereby clinicians, and the health service as a whole, will engage openly, transparently and compassionately with patients and their families when things go wrong.
Healthcare providers should familiarise themselves with their obligations under the Act and have appropriate systems in place to ensure full compliance. While the Act may present challenges for healthcare providers, they should ensure their staff are supported as we move into the new era of mandatory open disclosure.
For more information on this new legislation, please contact a member of our Medical Law team.
Compensation Payments in Catastrophic Injury Claims Reform on the way
Kevin Power Partner, Head of Medical Law kpower@mhc.ie
Healthcare litigation costs particularly in catastrophic injury cases continue to rise. This article reviews proposals regarding Periodic Payment Orders (PPOs) and the appropriate discount rate to be used in lump-sum settlements. Recommendations include a new indexation formula for PPOs along with regular reviews of the discount rate to maintain fair compensation levels. Our Medical Law team examines how the changes aim to provide more certainty and fairness in compensating those who suffer catastrophic injuries while addressing concerns of under-compensation.
The cost of healthcare claims in Ireland is rising. Over 50% of healthcare litigation costs annually are associated with catastrophic injury claims. The damages paid in these claims are broadly regarded as the main driver of increasing costs.
The recent working group report on the Rising Cost of Healthcare Claims made a number of recommendations for the faster and more efficient resolution of claims including:
• Resumption of the use of Periodic Payment Orders, or PPOs, by the courts, and
• Regular review of the discount rate, which is the rate of interest applied to calculate the current value of the cost of future losses
Jane Stanley Senior Associate, Medical Law jstanley@mhc.ie
Katie McAuliffe Senior Associate, Medical Law
kmcauliffe@mhc.ie
Separately, the Minister for Justice recently approved recommendations made in two working group reports from July 2024 on the indexation rate for PPOs and the discount rate. We review these recommendations.
Indexation rate working group
PPOs are an alternative to lump sum awards and are used to compensate those who have suffered catastrophic injuries. Instead of a single lump sum, payments are made annually on an agreed date to cover the cost of future care and treatment needs.
PPOs have not been used since a 2019 High Court decision 1. In that case, the Court ruled that the existing PPO legislation, which provided indexation of PPOs by reference to the Harmonised Index of Consumer Prices (HICP), would result in undercompensation of catastrophically injured persons over their lifetime.
In principle, PPOs are widely regarded as the preferred means of compensation in catastrophic injury claims. The annual payments reduce the likelihood that the injured person will run out of money to fund the cost of their future care and treatment needs. An indexation rate is applied to the annual payment amount to ensure it keeps pace with inflation.
1 Hegarty (a minor) v HSE [2019] IEHC 788
In response to the issues with the HICP index, a working group was established to advise on the appropriate indexation rate for PPOs. The group recommended:
• In the short term, the PPO indexation rate should be based on a combination of the HICP and the annual rate of change (ARC) in nominal hourly health earnings
• The amount of a yearly periodic payment payable should be based on a PPO indexation rate comprising 80% of average ARC in nominal hourly health earnings added to 20% of the HICP, and
• The Central Statistics Office structure of earnings survey expected to start from 2026 onwards will provide wage inflation figures for the health sector. These figures should be substituted for the ARC in nominal health earnings figures when calculating the PPO indexation rate.
Discount rate working group
The discount rate is the rate of investment return used by the courts to determine the size of a lump sum award needed to fully compensate a catastrophically injured person for their future losses. The higher the discount rate, the higher the level of expected return from investment and the smaller the compensation award amount. The lower the discount rate, the lower the level of expected return and, therefore, the higher the compensation award amount.
The current discount rate as determined in Russell v HSE 2 is 1% for future care costs and 1.5% for other economic or pecuniary losses.
A working group was established to provide advice on two key elements of the discount rate:
• The assumed risk profile of the injured persons, and
• An appropriate discount rate
The group recommended:
1. The discount rate should remain unchanged from the current rate.
2. No change is required to the 0.5% differential allowed for wage inflation.
3. Catastrophically injured persons should continue to be considered as having a riskaverse profile.
4. An expert group should meet every three years at a maximum to reassess the discount rate.
5. A “trigger” mechanism should be introduced to allow for any review of the discount rate, for example in the event of rapid changes to bond yields.
6. Any new judgment which may supersede the Russell judgments should also trigger a review.
Working group on the rising costs of healthcare claims
The group acknowledged that the fundamental solution to reducing these costs is rooted in the prevention of clinical harm arising from unanticipated events. A number of recommendations for the faster and more efficient resolution of claims were also made. The report echoed the need for courts to have the facility to use PPOs and also the need for regular review of the discount rate.
Other recommendations included:
• Changes to the management of clinical negligence claims including:
1. Introduction of pre-action protocols with sanctions for non-adherence to the protocols
2. Facilitation of earlier mediation, where possible
3. Amendments to case management rules to include a stipulation that equivalent rules apply to both sides
4. Joint expert meetings should be required
5. A dedicated court list should be established with judges in place with specialist knowledge of medical negligence litigation, or other measures to facilitate earlier hearing of cases
• A panel of medical expert witnesses who meet certain criteria should be developed and should be available to act on behalf of either party in litigation
• Medical record system with unique identifiers be put in place to facilitate better and more timely provision of medical records, including access to electronic records
Comment
Approval of the recommendations regarding PPOs is very welcome. Regulations are currently being prepared to implement these recommendations. It is hoped changes to the indexation rate will encourage catastrophically injured persons to avail of PPOs. The changes to the indexation rate should ensure payments are more closely tied to the actual costs of care and treatment over a person's lifetime providing certainty to injured persons and avoiding under-compensation. While the regulations are still awaited, there seems to be momentum for change and for PPOs to resume.
While certainty regarding the discount rate is also welcome, it is unclear how the recommendation of a ‘trigger event’ for the review of the discount rate will be dealt with in the awaited regulations. In addition, it is unknown how prescriptive the discount rate is, given that any new judgment which may supersede Russell would trigger a review.
It is hoped that the awaited regulations will lead to a revival of PPOs, which in our view are the best method of compensation in catastrophic injury cases. We await further developments in this space with interest.
For more information, contact a member of our Medical Law team.
Wearables and the Evolving Regulatory Landscape
Michaela Herron Partner, Head of Life Sciences mherron@mhc.ie
We explore rapid advancements in the field of Wearable technology and the new and evolving EU regulatory challenges that this can present for manufacturers and industry stakeholders.
This article highlights the importance of seeking expert legal guidance to stay informed on developing EU regulations. It also emphasises the need for maintaining effective strategies to ensure ongoing compliance in this dynamic regulatory environment.
Today, the interface between humans and technology is becoming more complex than ever. One of the most significant developments is the rise of Wearable technology, which is now a category made up of basic lifestyle trackers right through to advanced exoskeletons.
While consumer demand continues to drive manufacturers to constantly innovate and improve Wearable product functionality and performance, this can also result in increased regulatory complexity and compliance burden. We examine the Wearables regulatory ecosystem in light of several relevant legislative updates and what this means for securing and maintaining compliance with EU product requirements and by extension, access to the EU market.
Jamie Gallagher Partner, Life Sciences Regulatory jamesgallagher@mhc.ie
We have reviewed a broad spectrum of factors influencing the Wearable industry in previous insights including:
• Wearable Medical Devices: Current Challenges and Emerging Issues, and
• Fitness Trackers & Wearables – What are the Regulatory Risks?
We focus on how the legal landscape has evolved further in light of a number of important legislative developments.
Industry
The global fitness tracker market size continues to grow, with a recent valuation of $54 billion last year and a projected rise to $290.85 billion by 2032. Meanwhile, since they have entered the market, Wearables have evolved from the original basic recording of activity levels like step counts, to much more advanced physiological indicators like oxygen levels, respiratory rate, HRV and heart rate.
As the Wearable market continues to evolve, consumers now expect advanced capabilities and features. As a result, manufacturers and developers have needed to continually innovate and push product boundaries so that devices remain relevant and desirable to consumers. As a result, this has resulted in Wearables falling in scope of a much broader legal ecosystem than when these devices first entered the consumer market.
We look at each of the potential legal frameworks and flag some of the key considerations that Wearable industry stakeholders need to be mindful of. Given the various nuances under each legal regime, a careful assessment is required to determine what legal frameworks and more importantly what applicable obligations, are triggered by each specific Wearable.
What product safety framework applies?
Probably the most important initial assessment for a Wearable is its classification, which will dictate what product safety and compliance legislative framework it will need to comply with. For certain categories of products such as electrical equipment and Bluetooth / Wi-Fi enabled equipment, which would cover most Wearables, there are specific EU Directives such as the Radio Equipment Directive which will set out requisite product safety and compliance requirements. In the event that the Wearable does not utilise Bluetooth or Wi-Fi and does not engage any of the other sector specific legislation, which would seem unlikely, then the General Product Safety Regulation will apply to the product.
This replaces the General Product Safety Directive and comes into full effect from mid-December of this year.
While assessing whether the Wearable uses electronics or Wi-Fi or Bluetooth is straightforward, another question regularly arises and that is whether the Wearable could qualify as a medical device.
Is it a ‘medical device’?
Wearables associated with lifestyle or fitness tracking do not routinely fall within the scope of the medical device regulatory frameworks and more specifically under the EU Medical Devices Regulation (MDR). However, these products do require a thorough assessment in terms of their accessories, hardware, and software to determine if their specifications and features have brought them within the ambit of the EU medical device regulatory regime.
In determining whether a product falls within scope of the MDR (for the purposes of this article we are not examining the possible triggering of the IVDR), we need to assess the product against the definition of a medical device found in Article 2(1) which states that a medical device is:
“… 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[…]”
In order to answer this question, an assessment must be carried out as to whether the device is intended to be used for a medical purpose i.e. diagnosis, treatment, etc.? In addition to the device’s intended purpose, consideration must also be given to the product’s functionality and the claims the manufacturer intends to make about the product.
In practical terms, this means that regardless of the manufacturer’s stated intended use, products presented in a way that create an impression that they are to be used for medical purposes can also result in MDR applicability. For example, if a Wearable makes claims regarding medical benefits or diagnosis, then the device will most likely trigger MDR requirements.
Examples of Wearables that can qualify as medical devices in the EU are:
• Blood pressure monitors
• Glucose meters that help manage blood sugar levels for diabetics, and
• Heart rate monitors intended to detect irregular heart rhythms requiring further medical investigations.
Examples of Wearables that do not ordinarily qualify as medical devices in the EU can include:
• Fitness trackers that record steps and heart rate for wellness purposes
• Smart watches that record sleep habits for wellness purposes (and which don’t check for any sleep disorders).
If the product triggers the definition of a medical device, its risk class will then need to be determined with reference to the MDR Classification Rules set out in Annex VIII and it will be required to conform with the Essential Requirements in Annex 1.
Software as a medical device (SaMD)
With the integration of technology into Wearable devices, it’s not just the physical hardware that might be regulated as a medical device.
The integrated software can also potentially invoke the medical device frameworks where the software is considered to be a medical device in its own right. Furthermore, depending on functionality, where there is a mobile app operating alongside the Wearable, this could also potentially fall within scope of the MDR.
Assessing whether software qualifies as a medical device can be difficult because software and its integration with a given Wearable device varies in complexity, functionality, and risk. Helpfully, various pieces of guidance have been published to assist in assessing whether software is a medical device, classification of software medical devices as well as the relationship between hardware and software making up ‘systems’ regulated under the MDR.
Are data protection laws applicable?
The next key consideration is the data protection legislative framework.
Wearables, regardless of whether they fall in scope of the medical device regime, will almost always trigger the application of the GDPR. This is because Wearables collect, process, store and share a considerable amount of personal data. Often this can include sensitive data such as precise geolocation data or “special category data” under GDPR such as health data. For this reason, complying with GDPR can be challenging.
Some of the main obligations include:
Data protection by design
Manufacturers (as controllers under the GDPR) have an obligation to incorporate compliance with GDPR principles at the product development stage. GDPR principles include processing personal data fairly and transparently, processing personal data only for specified and explicit purposes (purpose limitation), processing only the personal data that is necessary for those purposes (data minimisation) and keeping data only as long as is necessary.
Manufacturers and developers will be expected to have given due regard to these principles when designing the Wearable and when processing the personal data generated by the Wearable. The onus is on the manufacturer to demonstrate compliance with this obligation. This can be demonstrated through carrying out privacy assessments such as a ‘data protection impact assessment’ (DPIA), where necessary.
A DPIA helps to assess the level of risk associated with the Wearable’s processing and identify appropriate safeguards and measures that should be in place. To properly assess such risks and ensure compliance, it is very important that crossfunctional teams work closely to understand the following issues:
• What data is processed?
• For how long is it retained?
• Who has access to the data?
• How is the data secured?
• With whom is the data shared?
Compliance cannot be treated as a last-minute consideration or an afterthought at the end of a product’s development. It must be ‘baked in’ during the product design and development process.
Lawfulness
Processing must also be lawful. There are six lawful bases set out in the GDPR which may apply to different aspects of the processing. In the context of Wearables, the most relevant bases for data processing are likely to include:
• Processing necessary for the performance of a contract with the user. This could include things like setting up a user’s account and providing the core functionality to the user, such as integrating the Wearable with other apps and services, and where requested by the user
• Processing necessary for the purpose of pursuing “legitimate interests”. This could be for product improvement purposes or research and development.
• Obtaining the consent of the user, such as for processing of health data (where explicit consent is often needed) or for advertising.
Understanding the nature of the data being processed is important to determine the appropriate legal bases. The correct determination is the responsibility of the manufacturer and will need to be relied on by a manufacturer.
Transparency
Users must have been provided with transparent information about the processing prior to any processing taking place. This means ensuring there is an appropriate privacy policy which explains what personal data is being collected and processed, the purposes of that processing (and the legal bases), how long the data is being kept and the third parties with which it is being shared. Steps must also be taken to ensure the privacy policy is accessible to users in an appropriate manner, such as surfacing it as part of the account creation flow or by way of email or in-app notification whenever there is a material update to the privacy policy.
Achieving compliance with lawfulness and transparency principles is also closely linked to the principle of fairness. Manufacturers should provide data subjects with clear and informative information which is not overly technical in nature to allow them to readily understand how their personal data will be processed. This means that information should be presented in straightforward language and be easily accessible.
Regulators take compliance with data protection principles, such as transparency and lawfulness, very seriously. Regulatory enforcement related to this aspect of the GDPR has often resulted in significant fines and remains an area of focus in the EU.
Data sharing and transfers
Manufacturers and developers who share personal data with third parties such as advertisers, or other third-party apps, must ensure that this data sharing is done in an informed and compliant manner. This means manufacturers must be clear with users about how their personal data will be shared with any third parties and the purposes for the sharing. In most cases, manufacturers might need to offer users a choice about whether such sharing takes place.
Manufacturers and developers should also consider their relationships with such third parties. Where there is a significant data sharing, it is often appropriate to put in place a contract governing the relationship which clearly states the role of the parties, how personal data can be used, and how data subjects’ personal data is fully protected. In cases where parties are jointly making decisions on how personal data is to be processed, they will be considered “joint controllers”. This can trigger additional obligations under GDPR, including the need to enter into a joint control arrangement and make the essence of this arrangement available to users.
If the manufacturer is transferring personal data of EU users to a third country, whether to an affiliate or a third party, then an assessment must also be completed to determine the appropriate transferring mechanism. If the recipient of the data is based in a country that is not deemed adequate by the EU, then in most cases, the manufacturer will need to put in place Standard Contractual Clauses (SCCs) or seek to rely on any certifications obtaining under the EU-US Data Privacy Framework.
Security considerations
Ensuring there is appropriate security in place to protect data being processed is critical. This involves ensuring data is appropriately stored securely, appropriate measures are in place to prevent unauthorised access and, access internally is limited to authorised employees and those who have a need to access such data, e.g. product improvement employees etc. It also involves regular testing to ensure safeguards and protections are robust.
The threat posed by criminals is significant with attacks on companies’ IT infrastructure becoming increasingly sophisticated, such as through ransomware attacks or phishing. It is critical that manufacturers ensure the measures in place are up to date and appropriate to its specific risks. This can include ensuring data is encrypted, ensuring the data is securely stored, and conducting regular software updates to ensure newly discovered vulnerabilities are addressed.
For example, if Wearable products are caught by NACE Code C26, then the NIS2 Directive would apply if the relevant company has at least 50 employees and over €10m in annual turnover.
In addition to having appropriate security in place, manufacturers should have appropriate policies in place to react to any security incidents if and when they arise. This involves implementing an incident response plan, developing policies and procedures which personnel can follow and understanding the various breach reporting and notification obligations that apply.
Will the Data Act apply?
The EU Data Act will also generate additional data obligations. This new legal framework applies to manufacturers of “connected products or related services” and so many Wearable manufacturers will fall in scope. Connected products could include pacemakers, continuous glucose monitors and smart insulin pens, as well as various Wearables, ingestible sensors, MRI and X-ray scanners.
The EU Data Act covers non-personal data and personal data and so, it is broader than the GDPR. As a result, the rules prescribed by the EU Data Act apply to data generated through use of the Wearable and its connected interface or integrated application. This encompasses data that users intentionally record, such as entering their menstrual cycle dates into the device’s interface, as well as data that is indirectly generated during periods of inactivity, for instance, when the device is in standby mode or even when it is turned off.
The EU Data Act creates rights and obligations for different parties.
In summary:
• The EU Data Act applies to manufacturer/ providers of connected products and related services.
• It creates onerous new obligations to make data directly accessible or at least readily available to users, third parties (where requested by the user) and public bodies (in exceptional cases).
• It imposes obligations that impact how products and services must be designed.
• It requires transparency to be given upfront to users about the data that will be generated through the connected products and related services.
• It requires manufacturers to make arrangements to share data with third parties (where requested by a user). This means manufacturers/providers need to consider measures (technical and contractual) to protect their interests and rights, such as IP/trade secrets.
• It gives users the right to make a complaint in the event there is non-compliance.
This EU Data Act is now in force; however, a transitional period of 20 months has been afforded meaning that it does not take effect until September 2025.
While manufacturers have some time before these rules become effective, now is the time to determine how compliance can be achieved given the scale of the new obligations and also how this new framework will co-exist with overlapping legislative regimes already in full force. Assessing how design and data access rules can be complied with, including how they interplay with the GDPR, and its associated cybersecurity obligations will be a difficult exercise for many.
Similarly, if Wearables designated as a medical device undergo significant modifications so as to comply with this new regime; this could result in adverse knock-on implications with respect to its compliance with the MDR or IVDR. As a result, manufacturers will need to carefully map the various regimes that may apply to its Wearables. From there, it will need to develop a well-structured and considered compliance plan.
Will the AI Act apply?
Another legislative regime that requires careful consideration is the recently enacted EU AI Act. This new legislative instrument is like many of the aforementioned regimes, in that it is far-reaching and onerous on certain uses of AI systems. As a result, manufacturers and developers incorporating the capabilities of AI must now determine whether the AI Act is applicable.
The AI Act is intended to be industry-agnostic, applying across a wide range of sectors including life sciences, healthcare, financial services and consumer products. It also applies to a broad array of economic operators active in the AI supply chain, including providers, importers, distributors, and deployers of AI systems as well as AI product manufacturers.
Each of the Wearables economic operators, if applicable, in the supply chain will have responsibilities. In this case the manufacturer / developers will be designated the providers of the AI system. Like many products, Wearables, including medical device Wearables, have integrated AI solutions into their devices’ development. As a result, the AI Act will be applied.
The next consideration is determining the level of risk associated with the intended use of the AI system. There are four risk categories prescribed by the AI Act:
• Unacceptable risk
• High risk
• Limited risk, and
• Minimal or no risk
Unacceptable risk includes AI systems which are considered a serious threat and will be banned from the EU market by 2 February 2025. An example would include Wearables whose specific purpose is to categorise individuals by using their biometric data to infer an individual’s race, religion, or sexual orientation. High-risk AI systems is the broader risk category and one which prescribes the most obligations.
Wearables incorporating AI which are classified as a medical device under either the MDR (or the IVDR) and which require Notified Body certification will fall within this category.
If a Wearable falls within the high-risk AI system category, a significant compliance undertaking will be required (including a pre-market launch conformity assessment and post-market monitoring regime). Specifically, seven detailed requirements require manufacturers and developers to substantially revise their processes and device procedures to ensure compliance with this regime. These are:
1. Risk management
2. Accuracy, robustness and cybersecurity
3. Data and data governance
4. Human oversight
5. Transparency and provision of information to users
6. Record keeping, and
7. Technical documentation
Some of these requirements are already provided for under the MDR (and IVDR). Manufacturers of Wearables in scope of these regimes are not required to carry out two distinct assessments. However, they must map the additional obligations required under the AI Act as part of a combined conformity assessment with the same market surveillance authority. While this is helpful, completing this gap assessment between the AI Act and the MDR / IVDR will require careful consideration and cross sector expert analysis.
Does the EU Batteries Regulation apply?
Again, as with most of the legislation referenced in this article, the new EU Batteries Regulation 1 is much wider reaching than that of its predecessor. This new regulation applies to all batteries as well as battery management systems, including those placed in or used for Wearables.
Like with the AI Act, the Batteries Regulation imposes obligations to entities across the economic chain including manufacturers, importers, and distributors of batteries and of medical devices that incorporate batteries. This includes those companies who produce these products. It also applies to companies who have the products produced for them and then sell the products under their own name or trademark.
The primary obligation under the Batteries Regulation is that batteries placed on the market or put into service shall not present a risk to human health, to the safety of persons, to property, or to the environment. However, the Batteries Regulation outlines more detailed obligations concerning sustainability, safety requirements, as well as labelling and information standards. Read more on the application of the Batteries Regulation to MedTech in our dedicated insight
1 Regulation (EU) 2023/1542
Consumer protection considerations
EU Consumer Protection laws have undergone significant reform over the last number of years to ensure more appropriate safeguards for consumers in today’s digital world. While there are too many to include here, by way of example, the Modernisation and Enforcement Directive 2019/2161, or ‘Omnibus Directive’, seeks to update and strengthen existing consumer protection laws through a range of measures. These include improved transparency and outcomes for consumers buying goods and services online and the identification and regulation of fake customer reviews and hidden paid-for advertising. The most significant feature of the Omnibus Directive is the increased enforcement for breaches of consumer law.
The Omnibus Directive seeks to impose fines of not less than 4% of the trader’s annual turnover, or at least €2 million when information on turnover cannot be obtained.
In addition, the Unfair Commercial Practices Directive (UCPD) underwent significant overhaul, last updated in March 2024 2. The Directive empowers consumers with a right to receive better protection against misleading information and commercial practices. As a result, not only must manufacturers be extremely careful of their claims and labelling so that they don’t inadvertently trigger the application of the medical devices regulatory regime, but they must also ensure that they don’t mislead consumers under the UCPD. Recent updates to the UCPD, inserted using the Green Transition Directive, have focused on combating misleading ‘green claims’ for instance, however, any false and inaccurate information which consumers rely upon to enter into a transaction to purchase products can result in adverse consequences for manufacturers.
2 Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information.
Liability considerations
To compliment the aforementioned consumer protection framework, reform is also underway regarding the rules governing EU product liability claims, which enable consumers to issue proceedings in relation to damage caused by defective products. A revised Product Liability Directive (the PLD) has now been adopted by the European Council which, amongst other things, extends the definition of product to include software and standalone software. Given that software is an integral part of Wearables, and that Wearables tend to be accompanied by apps, the revised PLD will have significant implications for manufacturers. In addition, for Wearables using AI, an AI Liability Directive is currently under consideration, which would seek to harmonise fault-based liability rules in National Member States and if adopted, would change the liability rules applicable to such devices.
The coming into force of other pieces of EU legislation like the Collective Redress Directive also brings with it an increased potential for litigation and class action-style claims brought by groups of EU consumers. This in turn increases the likelihood of a whole new body of case law forming across the EU concerning liability for defective Wearable devices and the software connected to them.
Sustainability legislative issues to be considered?
Ecodesign and Right to Repair
The EU is introducing a range of legislative measures aimed at achieving a more circular economy by encouraging consumers to choose repair over replacement. For example, the new Ecodesign for Sustainable Products Regulation entered into force on 18 July 2024. The new Right to Repair Directive entered into force on 30 July 2024, and Member States will be required to adopt national measures giving effect to this Directive by 31 July 2026 at the latest.
The Ecodesign Regulation applies to “any physical goods” placed on the EU market. The Regulation itself does not specify sustainability requirements for certain products. Rather, it creates a framework for the Commission to adopt information and/ or performance requirements in the context of product durability, repairability, energy efficiency, carbon footprint, etc. The Commission will initially focus on setting requirements for certain sectors including electronics and information and communications technology. The first of these ecodesign requirements are expected to apply from 2027/2028.
The Right to Repair Directive imposes repair obligations on manufacturers “of tangible movable items” across all industry sectors, whether they are established inside or outside the European Union. The scope of the repair obligation is currently limited to goods for which ‘repairability requirements’ are provided by another European Union Act listed in Annex II of the Directive. The repair obligation is also limited to circumstances where repair is technically possible.
The Directive introduces a “right to repair” for consumers, even beyond the expiry of the warranty period. This is to make it easier and more costeffective for consumers to repair products to keep them in circulation for longer.
Consumers will have the right to request that the manufacturer (or their repair sub-contractor) carry out a repair within a reasonable period of
time, either free of charge or at a reasonable price. Further, the Directive prohibits manufacturers from using contractual clauses, hardware or software techniques that impede the repair of goods unless these are justified by legitimate and objective factors.
This new eco-design and repair legislation will likely have a particular impact on manufacturers of products from the consumer and technology sectors. In particular, the Right to Repair Directive will open the aftersales markets for these products, although this will be subject to the requirement to offer repair either free of charge or at a reasonable cost. Manufacturers will likely face competition from independent repairers who may fix products at lower costs.
WEEE
The EU’s WEEE Directive aims to achieve collection, recycling, and recovery targets for waste electrical and electronic equipment (WEEE) by establishing extended producer responsibility (EPR) requirements. Broadly speaking, any entity placing EEE on the Irish market that is manufactured in its own name, imports EEE or sells EEE by distance sales is required to register as an EEE producer. Producers must file returns on the quantity of EEE they place on the market, contribute to the cost of the safe collection of WEEE from consumers, and display certain information regarding the hazardous properties of WEEE.
Packaging and packaging waste
The packaging of products also attracts environmental obligations. The EU’s Packaging Directive aims to achieve collection, recycling, and recovery targets for glass, plastic, paper, board, metal, and wood. Broadly speaking, businesses that sell or otherwise supply to other persons packaging material, packaging or packaged products above certain thresholds must join an EPR compliance scheme.
Obligations include reporting on the quantity of packaging placed on the market, financing the take-back of waste packaging, and ensuring minimum recovery targets are met.
Comment
Wearables have evolved significantly from their initial basic pedometer functionality to revolutionary tools that can transform lives. This evolution reflects a continued demand for enhanced functionality and innovative new features amongst a growing number of consumers of Wearable technologies. However, ground-breaking technological advancements can often come with an increased regulatory burden.
New legislative developments such as the Data Act, the AI Act and the proposed Product Liability Directive mean that manufacturers and developers must now consider a unique array of overlapping regulatory frameworks in respect of any given product.
Assessing which modern day Wearables trigger which frameworks can be challenging, seeing as many new laws now introduce novel and complex requirements. Additionally, understanding how each law aligns with the other is not always straightforward.
As a result, cross-sector specialist legal advice should be obtained by manufactures, developers and other industry stakeholders in order to determine what regimes are applicable and to construct a compliance strategy that satisfies the requirements of the various in scope frameworks in respect of any given product.
For more information and expert advice please contact a member of our dedicated Life Sciences team.
Top 10 Tips for Tenderers in Public Procurement Processes
Dorit McCann Partner, Head of Public Procurement dmccann@mhc.ie
Tendering for public contracts can be daunting, but avoiding common mistakes can significantly improve your chances of success. From understanding tender requirements to meeting deadlines, our Public Procurement team has compiled essential tips to help you navigate the process smoothly.
1. Understand the requirements and ask for clarifications
It is important to thoroughly review the tender documents as soon as they are issued. We often see tender documents where the requirements are unclear or ambiguous – the onus is on tenderers to ask for a clarification in these circumstances. This review should include a careful consideration of the terms of the contract to ensure tenderers understand them and can sign up to them.
Any clarifications or requests for amendments should be sought as early as possible as the contracting authority will usually not be able to make changes to the contract at a later stage in the process. Make sure you read all clarifications issued by the authority to make sure you understand and track them and adhere to the revised requirements. If necessary, ask a follow up question.
Ruairí McDermott Senior Associate, Public Procurement rmcdermott@mhc.ie
2. Ensure you meet the qualification criteria
We often advise contracting authorities regarding tenders that do not meet all of the qualification criteria. This could be down to a simple mistake, e.g. a document that was not uploaded, or a misunderstanding of the requirements.
As a general rule, the authority is not required to clarify mistakes or request missing documents and often has very little discretion in these circumstances. It may have no choice but to reject your tender as it otherwise risks a challenge from one of the other tenderers who has complied with all qualification criteria. To avoid this, we advise that another person reviews the completed tender documents before submission to ensure that nothing has been missed.
3. Submit a clearly structured tender response that addresses all of the points in the award criteria
Carefully review the tender documents. Provide a clear and concise response to each requirement. Ensure that your answers demonstrate the knowledge, experience and skills of your organisation. Responses should be directly mapped to the requirements in the award criteria, using clear headings and highlighting how your response meets or exceeds the requirements.
Make sure you understand the scoring methodology for each question to ensure you maximise your scores. Don't leave any room for confusion or ambiguity as this may result in a lower score.
4. Do not rely on the fact that the authority knows you from previous projects
Tenderers often fail to set out clearly how their organisation can provide what the authority wants, sometimes assuming that the authority already knows them and their offering. It is important to remember that the authority can only evaluate you against the information in your tender. The authority is not permitted to take into account any other information. Also, the evaluation team in a procurement process is often different to the contract managers with whom you may have a good relationship. It is therefore important that you include all relevant information in your tender response.
5. Be clear on the team and the roles of each member
We often see inconsistencies regarding team members and their roles and responsibilities. Make sure that the titles, qualifications and experience of team members precisely match the requirements in the tender documents. If permitted, include an organisational chart and clearly describe each team member’s role, highlighting their qualifications, experience, and reporting structures.
6. Do not include hyperlinks in your tender response unless expressly requested in the tender documents
The issue with hyperlinks is that the documents are not under the contracting authority’s control until they are downloaded from the hyperlink. This means that they could be altered after the tender deadline. This scenario was highlighted in a recent EU judgment where the court held that the contracting authority was entitled to reject a tender with a hyperlink, through which the authority could download samples which were required to be submitted by tenderers.
7. Adhere to word/page counts
Word and page counts are often included in tender documents, together with specifications on font and font size. It is vitally important to stick to the specific requirements in the tender document and to clarify any inconsistencies or missing information. For example, do charts, tables and CVs form part of the word/page limit? Is there a numbering protocol for appendices? Depending on the rules in the tender document, the authority will often stop reading once the word/page limit is reached. Therefore, if important information is included in the words or pages beyond the limit, they may not be evaluated and could lead to a lower score or even to disqualification.
8. Price
Calculation errors are among the most frequent mistakes we see – carefully go over your calculations before submission and adhere to the guidance notes on pricing, e.g. are zero rates permitted? Can additional lines be added to the document? Do not make any changes or include any assumptions in your pricing document unless expressly permitted by the authority, as this could disqualify your tender.
9. Do not miss the deadlines!
Ensure you have sufficient time for upload of documents. Late tenders will usually not be accepted unless it can be proven that the delay was not the tenderer's fault and that no changes were made to the tender document after the tender deadline.
10. Study the standstill letter carefully
The standstill letter must include certain information, including:
• The name of the successful tenderer
• The standstill period
• Your scores and those of the successful tenderer, as well as
• The characteristics and relative advantages of the successful tender
Our recent insight on standstill letters provides further information. The debrief should be sufficiently clear to allow you to understand why you have lost and how you could have improved your tender. If the reasoning in the standstill letter is too bland or is missing information, you can ask for additional debrief information. If the authority is covered by the Freedom of Information Act, you could make a FOI request to get further information. However, if you feel you were treated unfairly, do not delay in getting legal advice as there is very limited time in which you can challenge a tender process.
Conclusion
We guide tenderers through all stages of a public procurement process and advise them on strategy. We also advise on the strengths of a potential challenge and the avenues open to unsuccessful tenderers.
For more information on any public procurement issue, please contact a member of our Public Procurement team.
Autumn 2024 Government Priority Legislation Programme
Catherine Allen Partner, Head of Public, Regulatory & Investigations callen@mhc.ie
The Government recently published its Autumn Legislation Programme. The key legislative aims for this autumn session include increasing sentencing penalties, working beyond mandatory retirement age, surrogacy and as always, health and housing. We discuss some of the proposed legislation.
The Autumn Legislative Programme is an ambitious one as it may be the last programme of this current Government. 61 priority pieces of draft legislation (Bills) have been listed for progression in the autumn sitting of the Dáil. Of these 61 priority Bills, 29 will be prioritised for publication and 32 will be prioritised for drafting.
In launching the programme, Government Chief Whip, Hildegarde Naughton TD stated: “Since my appointment as Government Chief Whip in December 2022, Government has overseen the enactment and publication of 148 pieces of legislation, all of which contribute towards making life a little bit easier for families, for workers, for farmers and for society as a whole. Since the formation of this Government (June 2020), 211 bills have been published and 203 bills have been enacted.”
The complete Autumn Legislation Programme 2024 can be accessed online
Public Sector
The Employment (Restriction of Certain Mandatory Retirement Ages) Bill will remove the ability of an employer to force an employee to retire once they reach State pension age. The pre-legislative scrutiny stage of this Bill has been completed.
Laura Rattigan Senior Associate, Public, Regulatory & Investigations
lrattigan@mhc.ie
Work is ongoing on the Civil Service Regulation and Public Service Management (Amendment) Bill. The Bill aims to amend existing legislation to provide for disciplinary action, including procedures for the dismissal of civil servants. The Ethics in Public Office Bill aims to reform and consolidate the Ethics in Public Office legislation.
Regulatory Bodies
The Gas Safety (Amendment) Bill has concluded its detailed examination (pre-legislative scrutiny) phase. This Bill will make a number of amendments to existing legislation focused on ensuring that third party operators of Liquid Petroleum Gas networks are fully incorporated into the Commission for Regulation of Utilities’ (CRU) regulatory regime. Work is ongoing on the Railway Safety (Amendment) Bill, which includes proposals to update provisions in the Railway Safety Act 2005 relating to functions of the Commission for Railway Regulation.
Pre-legislative scrutiny of the Environment (Miscellaneous Provisions) Bill completed in July 2024. One of the chief aims of this Bill is to enable the Environmental Protection Agency (EPA) to be more efficient and effective in its determinations. It will do so by providing a streamlined approach for decision-making and shortening the period for final determinations of industrial emissions and waste licences of the EPA. Heads are in preparation of the Heat (Networks and Miscellaneous Provisions) Bill, which aims to establish a regulatory model for district heating that ensures consumer protection and the delivery of a vibrant district heating industry.
Meanwhile, heads have been approved in the Regulated Professions (Health & Social Care) (Amendment) Bill, which will amend the Health and Social Care Professionals Act 2005, the Medical Practitioners Act 2007, and the Dentists Act 1985. The aim is to create internal operational efficiencies to support the regulators in fulfilling their public protection objectives. Similarly, work is underway on the Health (Pharmacy and Prescribing) Bill, which aims to update the Pharmacy Act 2007 to enable the Pharmaceutical Society of Ireland (PSI) to streamline functions, such as fitness to practice processes.
Health
Heads of Bill are in preparation for the Health (Assisted Human Reproduction) (No.2) Bill, which will address issues related to parentage and citizenship arising from the use of fertility clinics abroad by Irish residents and Irish citizens living abroad.
The Health (Amendment) Bill features again in the Government’s priory legislative programme. Its aim is to amend the Health Act 2004, by introducing corporate governance, planning and budgetary measures. The Health (Amendment) (Licensing of Professional Home Support Providers) Bill is undergoing pre-legislative scrutiny. This Bill will establish a regulatory framework for licensing home support providers. The aim is to ensure that all service users receive high-quality care in accordance with HIQA national standards.
While not a priority piece of legislation, work is continuing on The Patient Safety (Licensing) Bill. This Bill will introduce a licensing requirement for all hospitals, public and private, and certain designated high-risk activities in the community.
Housing and property
Pre-legislative scrutiny of the Housing (Miscellaneous Provisions) (No.2) Bill has been completed. This Bill will amend the Housing Acts to provide for more social housing, the regulation of Approved Housing Bodies and amendments to the Building Controls Acts. Heads have been approved for the Remediation of Defects in Apartments and Duplexes Bill, which aims to establish a remediation scheme for apartments and duplexes
that were built between 1991 and 2013, and which have fire safety, structural safety and water ingress defects. In conjunction with this, heads are in preparation for the Building Standards Regulatory Authority Bill. The Bill aims to provide for the establishment of a Building Standards Regulatory Authority. The purpose of the Authority is to strengthen the oversight role of the State in the design and construction of buildings and the marketing and use of construction products.
Policing and defence
Drafting is ongoing with the Garda Síochána (Powers) Bill. This Bill will codify police powers of search, arrest, and detention and procedural rights of suspects and take into account developments in modern technology. Additionally, in fulfilment of the Government’s objective of making the streets safe for people, pre-legislative scrutiny of the Garda Síochána (Recording Devices) (Amendment) Bill has concluded. This controversial Bill will allow for the use of facial recognition technology (FRT) for serious offences.
Notably, and in conjunction with the aim of making the streets safe for people, heads of the Life Sentences Bill have been approved. This Bill will allow judges to impose a minimum sentence to be served before parole can be considered.
Conclusion
The Autumn Legislative Programme 2024 reflects a continuation by the Government of priorities such as healthcare, housing, and policing and defence, which were previously addressed in the Summer and Spring Legislative Programmes.
For more information on the Autumn Legislative Programme, contact a member of our Public, Regulatory & Investigations team.
Catherine Allen Interview on Ireland’s Covid-19 Inquiry
Catherine Allen Partner, Head of Public, Regulatory & Investigations callen@mhc.ie
Catherine Allen, Partner and Head of our Public, Regulatory & Investigations team, recently contributed to the Irish Times video on Ireland’s Covid-19 inquiry
It is expected that the inquiry will be established by the Irish Government to investigate the handling of the pandemic in healthcare settings such as hospitals and nursing homes.
The Terms of Reference for the inquiry are due to be announced shortly.
Catherine discussed the likely goals of the inquiry, the difference between statutory and non-statutory inquiries and the approach the Government is expected to take.
Watch the video on the Irish Times website here, or read our latest insight on the Covid-19 inquiry
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