The HIMSS Electronic Health Record Association in the US has gone to respond to a new request pertaining to the information from the US Department of Health and Human Services by seeing it as a very crucial opportunity in order to examine regulations that don’t reflect the present technology or market realities and also go ahead and make corrections to the misaligned approaches when it comes to rulemaking.

It is well to be noted that EHRA submitted the comments pertaining to its reform as well as regulatory priorities to the HHS. This was in response to its request for information (RFI) ensuring lawful regulation and unleashing innovation to make America healthy again request for information. Apparently, the EHR has asked the HHS to modernizing the regulatory approach to RFI.

In its comprehensive response, EHRA went ahead and stressed the critical requirement for regulatory modernization in order to keep pace with the rapid technological advancements within digital health. The association specifically called for updates to the present regulatory approach that surrounds the RFIs and other policymaking processes, arguing that the outdated frameworks go on to create unnecessary barriers to innovation within electronic health records and related health IT solutions. The recommendation of EHRA happens to focus on creating a more flexible, responsible regulatory environment that can go ahead and adapt to the emerging technologies such as AI, interoperable systems, and also patient-centered care models and, at the same time, make sure that compliance with the present laws takes place.

Through submitting these recommendations, EHRA looks forward to supporting HHS in developing regulations that both protect the patients and also empower the healthcare organizations to leverage cutting-edge technologies in an effective way. The association emphasized that the modernized regulations are going to be very critical for achieving nationwide interoperability, thereby ultimately enhancing the health outcomes throughout the care continuum.

Why all this makes a difference?

The coalition of health technology vendors has long held the fact that an expansion of Food and Drug Administration oversight of medical device regulation to technology that is subject to oversight already by way of the Office of the National Coordinator for Health Information Technology Certification Program happens to go beyond the statutory boundaries of the 21st Century Cures Act.

The EHR Association, in a comment letter on July 14, 2025, said that as the federal government looks forward to modernizing its regulatory approach and also supporting innovation throughout healthcare, it hence urges HHS to focus on clarity, alignment with statutory intent, and at the same time, elimination of low-value or duplicative regulatory needs.

It is worth noting that the organization’s position is that EHR systems should not get regulated as medical devices, and there is in place a guidance issued in 2022, which is having a chilling effect on developers willingness to invest in tools that are required to support public health along with value-based care programs. The organization said that the EHR association goes on to urge the EHS to revoke the final guidance on clinical decision support software from the FDA, which nearly conflicts with the seven principles that are already outlined in the executive order 14219.

Notably, the guidance lacks the statutory grounding and introduces legal ambiguity and at the same time also imposes excessive costs along with deterring innovation. Rather, the EHR Association went on to say that the FDA should reinstate or even revise the 2019 draft guidance to explicitly go ahead and exclude CDS functionality, which is embedded within the certified EHRs, and also eradicate new regulatory constructs, which include time-critical decision-making along with automation bias that was introduced in the latest guidance.

According to the trade organization, other HHS regulations along with policies also happen to fall within the deregulatory scope that has been outlined in the executive order 14212 by the Trump administration.

These happen to include clarifying predetermined change control plan requirements, which address the bias when it comes to classifying products as devices that happen to impose user fees. Altering outdated HIT certification testing tools and, at the same time, better defining certain aspects of interoperability requirements.

It is well to be noted that the organization also went on to urge HHS to go ahead and clarify electronic case reporting requirements, which include automated reporting of public health conditions along with chronic disease indicators, and also offer adequate funding as well as technical support for the Centers for Disease Control and state, tribal, and local as well as territorial authorities.

The EHR Association said that rather than deregulation in this case, success happens to depend on stability, coordination, as well as capacity building.

What’s the larger trend?

In January 2025, the FDA said that while it happens to be committed to rolling out new medical devices at a much faster pace, it is going to take a science-based approach when it comes to requirements for medical devices that are powered by artificial intelligence as well as machine learning.

Thereafter, in April 2025, the assistant secretary for technology policy went on to update the guidance that healthcare organizations use to assess and optimize the safety of their EHRs. The 2025 safety assurance factors when it comes to EHR resilience guides happen to contain CURES Act revisions, which also include the use of AI for clinical care, integration of FDA-approved medical device data into EHRs, and cybersecurity.

The EHRA said in its letter that as the federal government looks forward to modernizing the regulatory approach to RFI and supporting innovation through healthcare, they urge the HHS to focus on clarity, alignment with statutory intent, and also eradication of low-value or duplicative regulatory needs. The letter further added that the recommendations with regard to this response happen to reflect the practical realities that their member companies face when it comes to delivering high-quality, patient-centered, and interoperable digital health tools.

The Ministry of Finance in China on July 10 detailed out the measures that the country has taken against medical devices imported from the EU by way of government procurement projects. The ministry said in a notice on July 6 that when a purchaser happens to buy medical devices with a budget of more than 45 million yuan, which is about $6.2 million, if it is deemed necessary to purchase imported products by going through relevant legal procedures, the participation of EU enterprises, which excludes funded enterprises within China, should be excluded.

It is well to be noted that on July 10, when answering a question pertaining to the budget threshold of 45 million yuan, the ministry went on to say that if a budget reaches 45 million yuan or even more, the measures stipulated within the notice are going to be implemented in spite of whether the procurement happens to involve single-unit purchases of a specific product type, purchases of a specific type related to any sort of bulk buying, or the obtaining of varied kinds of products.

Interestingly, the EU-funded enterprises in China can very well participate in the government procurement projects that involve the purchase of medical devices that exceed a cost of more than 45 million yuan. However, if these products that they provide include medical devices imported from the EU, the value of the medical devices that are imported from the EU should not exceed half of the total contract value, as per the ministry.

The state-owned enterprise procurement in China is not categorised under the government procurement, and this notice does not apply, the ministry added.

Apparently, China’s commerce ministry spokesperson on July 6 had said that the European Commission had introduced measures on June 20, 2025, in order to restrict the Chinese enterprises as well as products from participating in the public procurement of medical devices in the EU, and the barriers continue to grow for the Chinese firms when it comes to public procurement.

The spokesperson added that China had repeatedly expressed, by way of bilateral dialogue, its willingness to go ahead and resolve the differences with the EU through dialogue and also via consultation as well as bilateral government procurement arrangements. However, in spite of the goodwill and sincerity by China, the EU has insisted on taking measures that are restrictive in order to build new protectionist barriers.

Hence, China has no choice but to go ahead and take reciprocal restrictive measures in order to safeguard the legitimate rights as well as interests of the enterprises in China and to maintain a fair competition scenario, said the spokesperson.

Phillips went ahead and announced its collaborations with four leading critical care companies – Hamilton Medical, Getinge, Drager, and a leading infusion pump company, B. Braun Melsungen AG, in order to drive the operational enhancement and improve the hospital experience when it comes to patients as well as clinicians.

It is well to be noted that these collaborations happen to be centred around service-orientated device connectivity – SDC benchmarks, which help with interoperability throughout medical devices as well as platforms. SDC happens to support a common language between SDC-certified medical devices so that the clinicians can seamlessly see as well as act upon data derived from these technologies, in spite of their device manufacturer.

The open patient monitoring ecosystem of Philips helps partnerships along with outside device manufacturers, thereby enabling the future of enhanced connectivity throughout the hospital. This is a prominent step towards what Phillips calls a smart healing environment, wherein the facilities will be able to consolidate alarms and, at the same time, feed them into management workflows, which go on to meet the clinicians wherever they are.

This is going to definitely support a future system of integrated third-party devices that will enable a holistic view of patient information in one place, thereby helping the clinicians to track patients remotely and at the same time inform quicker care decision-making. The impact of these partnerships is immense, and they do sync in with the philosophy of improving care.

Alarm management when it comes to enhanced patient care

It is worth noting that alarms happen to play a very important role when it comes to hospitals by way of helping the clinicians to go ahead and respond to the needs of the patients.

The pervasive issue of alarm fatigue within hospitals goes on to represent a very crucial patient safety concern that happens to demand immediate attention. With clinicians being bombarded by hundreds of daily alarms per patient, the majority of which are either non-urgent or false, healthcare providers are faced with an unsustainable situation that compromises care quality. This kind of constant auditory assault not just desensitizes the medical staff to certain potentially critical alerts, but at the same time, it also goes on to create a very chaotic environment that negatively affects the recovery of patients. Studies happened to show that the stress from incessant alarms can elevate the blood pressure and also the heart rate in patients, thereby, ironically, triggering more monitor alerts when it comes to this vicious cycle.

It is well to be noted that Phillips does recognise that this kind of multifaceted challenge needs a systematic and collaborative approach. Through working with technology partners, they are developing integrated solutions that apply intelligent algorithms in order to prioritise as well as suppress non-critical alarms, while at the same time ensuring that genuine alerts go on to receive appropriate care and attention. Their approach happens to focus on three major areas: first, going ahead and implementing smart thresholds, which comprise individual patient baselines and not the generic parameters.

Second, coming up with unified alarm management platforms that aggregate as well as prioritise alerts throughout different tracking systems. And third, introducing a visual alarm notification system, which decreases the auditory overload while at the same time maintaining the clinical awareness.

Apparently, these technological advancements happen to be complemented by work designs that helped the clinicians to better manage responses without compromising on the vigilance. The objective is to transform hospitals from environments of constant noise to spaces of healing where the technologies support and not disrupt the care process. By way of these innovations, Phillips aims to reduce the false alarms and, at the same time, make sure that critical patient events never go unnoticed.

This is going to be made possible due to the following key actions that must be taken:

1. Consolidating the alarm notifications – Since the clinicians will be able to get as well as act upon alarm notifications coming from multiple devices, they will be able to review as well as manage alarms from anywhere within the hospital, thereby streamlining the clinical work workflows.
2. Creating the capacity in order to treat more patients – As hospitals continue to grapple because of staffing shortages, alarm management enables Freeing up clinical capacity by allowing the clinicians to track as well as address patient alarms while at the same time treating other patients where they are.
3. Reduction of noise in patient rooms – Enhancing connectivity will also help devices to share data bi-directionally so that the clinicians can view as well as manage alarms from anywhere they are, which may also help in reducing the noise within patient rooms.
4. Enhancing the response times – SDC will also enable timely intervention since the clinicians will be able to raise alarms as required from their mobile devices, thereby helping them to deliver prompt care across patients.

Powering smart healing environment by way of open and connected systems

Clinicians happen to make critical decisions every day that are based on data coming from a wide array of medical devices. Many of these devices don’t talk to each other, however, it is indeed now the time to simplify that reality. Through making data more accessible by way of SDC, a smart healing environment is created by Philips that happens to work better for both patients as well as clinicians.

The fact is that the challenges that the patients as well as the clinicians face are indeed very real, and Phillips is on the cusp of making a very meaningful as well as lasting effect. These collaborations mark a key landmark when it comes to the advancement of medical device connectivity, thereby making the open ecosystem a benchmark within the healthcare spectrum in order to enhance the experience pertaining to hospitals when it comes to one and all.

Partnership helps hospitals to extend reach beyond existing facilities while providing seamless patient care

Singapore, 15th July 2025 – InterSystems, a creative data technology provider managing over one billion healthcare records globally, and MyCLNQ Health, a digital health solutions leader, have announced a regional strategic partnership to help hospitals enhance patient engagement and increase service offerings across Asia. As part of the collaboration MyCLNQ will embed the InterSystems IRIS for Health™ data platform into its customizable, white-label mobile technologies to provide interoperability between MyCLNQ and other hospital systems for seamless patient care.

At the core of this partnership is a shared vision to create seamless, real-time engagement between hospitals and their patients. By combining InterSystems’ robust interoperability capabilities with MyCLNQ’s flexible mobile health solutions, hospitals across the region can now enhance care delivery, reduce integration complexity, and elevate patient satisfaction without needing to build their own patient-facing apps or expand IT teams.

“This partnership addresses a very real need for hospitals navigating digital transformation,” said Luciano Brustia, Regional Managing Director, Asia Pacific at InterSystems. “Healthcare institutions are under pressure to expand service offerings and to meet patients’ growing expectations of the care experience that should be convenient without compromising continuity of care. In partnership with MyCLNQ we are helping hospitals go beyond their traditional boundaries and deliver better care through real-time digital engagement.”

MyCLNQ Health currently operates in over eight countries, including Singapore, Indonesia, Malaysia, Vietnam, and Cambodia, offering a customizable and multilingual platform that allows hospitals to personalize features based on patient demographics and institutional needs. The white-label nature of MyCLNQ’s solution means hospitals can deploy a branded, patient-facing app rapidly while maintaining full visibility over the patient journey.

Comprehensive Patient Engagement Features

The partnership unlocks a range of tools for hospitals, such as real-time notifications and reminders, live reporting, ambulance bookings, satisfaction tracking, teleconsultation, and access to medical history. MyCLNQ enables providers to manage both patient and healthcare provider engagement on one unified platform, streamlining workflows and improving outcomes.

“We built MyCLNQ with the goal of empowering patients through convenient, technology-driven access to healthcare,” said Anwar Rafique, Co-Founder and CEO of MyCLNQ Health. “Our mobile app helps users book appointments, consult with doctors, and receive medication at home. With InterSystems IRIS for Health as the data platform, we can scale this experience across more hospitals, faster and more efficiently.”

InterSystems IRIS for Health is purpose-built to facilitate healthcare application development and interoperability at scale. Hospitals already using InterSystems platforms can integrate MyCLNQ Health with minimal time and cost, enabling rapid adoption without disrupting existing systems. For healthcare providers not yet on InterSystems, MyCLNQ Health can still be adopted seamlessly, thanks to InterSystems’ robust interoperability with healthcare standards and its scalable architecture, ensuring smooth integration with existing systems.

Empowering Hospitals with End-to-End Digital Solutions

MyCLNQ Health enables users to stay connected to their preferred healthcare providers while traveling, through a cross-border model supported by integrated payment systems and access to international medical professionals. Hospitals benefit from an end-to-end digital solution that can be launched without investing in new infrastructure or additional human resources.

The collaboration is driven by three key goals: increasing patient engagement, improving satisfaction, and empowering hospitals to extend their reach beyond their physical facilities. In a region where national blueprints are pushing for digital-first healthcare, the InterSystems–MyCLNQ partnership offers a tangible and scalable way to meet government mandates and patient expectations alike.

Looking ahead, both companies are committed to continuing innovation that supports connected care ecosystems, from primary care to diagnostics, insurance, and home health. Data captured via the MyCLNQ app, such as consultations, prescriptions, and patient feedback, can be securely fed back into the hospital’s system via InterSystems IRIS for Health, providing clinicians and administrators with a single, real-time view of each patient.

With hospitals seeking smarter, faster, and more cost-effective ways to modernize, this partnership delivers a future-ready model for patient-centric care, secure, scalable, and built for Asia’s dynamic healthcare landscape.