Regulations and Reimbursement of Digital Therapeutics: A Review of Current Global Practices and Future Prospects

Author(s):  
Amit Dang ◽  
Dimple Dang ◽  
Pawan Rane

: The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.

2020 ◽  
Author(s):  
Charis Xuan Xie ◽  
Christopher Maher ◽  
Gustavo C Machado

With the widespread uptake of EMRs across the world, massive health-related datasets have been generated and clinicians are often overwhelmed with the complexity in analysing those EMR data. To overcome this, digital health dashboards have been integrated into EMR systems to help clinicians make informed decisions and ensure reliable care delivery. Despite its increasing popularity in the healthcare setting, there is limited summary evidence investigating the effectiveness of digital health dashboards to improve healthcare delivery and patient outcomes. In this systematic review, we aim to look at the impact of digital health dashboards on the healthcare system, clinicians and patients. The objectives are to: i) investigate the effectiveness of digital health dashboards for improving healthcare delivery and patient outcomes in primary care and hospital settings, and ii) identify the types of dashboards and describe its features and visualisation techniques. This is the final version of the systematic review protocol, published as a preprint to create full transparency about the review process.


Author(s):  
Sheri Palejwala ◽  
Jonnae Barry ◽  
Crystal Rodriguez ◽  
Chandni Parikh ◽  
Stephen Goldstein ◽  
...  

2012 ◽  
Vol 9 (2) ◽  
pp. 96-98
Author(s):  
Brian A Bruckner ◽  
Matthias Loebe

Patients undergoing re-operative cardiac surgical procedures present a great challenge with regard to obtaining hemostasis in the surgical field. Adhesions are ever-present and these patients are often on oral anti-coagulants and platelet inhibitors. As part of a well-planned surgical intervention, a systematic approach to hemostasis should be employed to decrease blood transfusion requirement and improve patient outcomes. Topical hemostatic agents can be a great help to the surgeon in achieving surgical field hemostasis and are increasingly being employed. Our approach, to these difficult patients, includes the systematic and planned use of AristaAH, which is a novel hemostatic agent whose use has proven safe and efficacious in our patient population.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041743
Author(s):  
Christina Østervang ◽  
Annmarie Touborg Lassen ◽  
Charlotte Myhre Jensen ◽  
Elisabeth Coyne ◽  
Karin Brochstedt Dieperink

IntroductionThe development of acute symptoms or changes in diseases led to feelings of fear and vulnerability and the need for health professional support. Therefore, the care provided in the acute medical and surgical areas of the emergency department (ED) is highly important as it influences the confidence of patients and families in managing everyday life after discharge. There is an increase in short-episode (<24 hours) hospital admissions, related to demographic changes and a focus on outpatient care. Clear discharge information and inclusion in treatment decisions increase the patient’s and family’s ability to understand and manage health needs after discharge, reduces the risk of readmission. This study aims to identify the needs for ED care and develop a solution to improve outcomes of patients discharged within 24 hours of admission.Methods and analysisThe study comprises the three phases of a participatory design (PD). Phase 1 aims to understand and identify patient and family needs when discharged within 24 hours of admission. A qualitative observational study will be conducted in two different EDs, followed by 20 joint interviews with patients and their families. Four focus group interviews with healthcare professionals will provide understanding of the short pathways. Findings from phase 1 will inform phase 2, which aims to develop a solution to improve patient outcomes. Three workshops gathering relevant stakeholders are arranged in the design plus development of a solution with specific outcomes. The solution will be implemented and tested in phase 3. Here we report the study protocol of phase 1 and 2.Ethics and disseminationThe study is registered with the Danish Data Protection Agency (19/22672). Approval of the project has been granted by the Regional Committees on Health Research Ethics for Southern Denmark (S-20192000–111). Findings will be published in suitable international journals and disseminated through conferences.


2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Abbott ◽  
K Bishop ◽  
F Hill ◽  
C Finlow ◽  
R Maraj

Abstract Introduction In September 2017 our frailty service was started within our medium sized DGH in North Wales. Working with our management team we secured a significant clinical resource including: We describe how resources, setting and staffing develop over a 2 year period in order to create a service which meets the needs of the local population. Method The service has been in a constant state of development since it has been in operation, utilising a PDSA model with regular meetings of clinical and managerial staff to analyse performance. Results With each new PDSA cycle the amount of patients reviewed has increased. With the move to AMU we increased the monthly number of patients reviewed from 29 to 172 patients reviewed, 97 of which were discharged directly from the unit. Conclusion Using QI methodology our Frailty Service has improved dramatically since its inception. We will continue to analyse how we work to improve patient outcomes and cost effectiveness.


2021 ◽  
Vol 13 (9) ◽  
pp. 4839
Author(s):  
Satoru Kikuchi ◽  
Kota Kadama ◽  
Shintaro Sengoku

In recent years, technological progress in smart devices and artificial intelligence has also led to advancements in digital health. Digital health tools are especially prevalent in diabetes treatment and improving lifestyle. In digital health’s innovation ecosystem, new alliance networks are formed not only by medical device companies and pharmaceutical companies but also by information and communications technology (ICT) companies and start-ups. Therefore, while focusing on digital health for diabetes, this study explored the characteristics of companies with high network centralities. Our analysis of the changes in degree, betweenness, and eigenvector centralities of the sample companies from 2011 to 2020 found drastic changes in the company rankings of those with high network centrality during this period. Accordingly, the following eight companies were identified and investigated as the top-ranking technology sector companies: IBM Watson Health, Glooko, DarioHealth, Welldoc, OneDrop, Fitbit, Voluntis, and Noom. Lastly, we characterized these cases into three business models: (i) intermediary model, (ii) substitute model, and (iii) direct-to-consumer model, and we analyzed their customer value.


2021 ◽  
Vol 22 (5) ◽  
pp. 481-508
Author(s):  
Robert P. Carlyon ◽  
Tobias Goehring

AbstractCochlear implants (CIs) are the world’s most successful sensory prosthesis and have been the subject of intense research and development in recent decades. We critically review the progress in CI research, and its success in improving patient outcomes, from the turn of the century to the present day. The review focuses on the processing, stimulation, and audiological methods that have been used to try to improve speech perception by human CI listeners, and on fundamental new insights in the response of the auditory system to electrical stimulation. The introduction of directional microphones and of new noise reduction and pre-processing algorithms has produced robust and sometimes substantial improvements. Novel speech-processing algorithms, the use of current-focusing methods, and individualised (patient-by-patient) deactivation of subsets of electrodes have produced more modest improvements. We argue that incremental advances have and will continue to be made, that collectively these may substantially improve patient outcomes, but that the modest size of each individual advance will require greater attention to experimental design and power. We also briefly discuss the potential and limitations of promising technologies that are currently being developed in animal models, and suggest strategies for researchers to collectively maximise the potential of CIs to improve hearing in a wide range of listening situations.


Neurosurgery ◽  
2021 ◽  
Author(s):  
Kelly M Poth ◽  
Pavlos Texakalidis ◽  
Nicholas M Boulis

Abstract The field of chemogenetics has rapidly expanded over the last decade, and engineered receptors are currently utilized in the lab to better understand molecular interactions in the nervous system. We propose that chemogenetic receptors can be used for far more than investigational purposes. The potential benefit of adding chemogenetic neuromodulation to the current neurosurgical toolkit is substantial. There are several conditions currently treated surgically, electrically, and pharmacologically in clinic, and this review highlights how chemogenetic neuromodulation could improve patient outcomes over current neurosurgical techniques. We aim to emphasize the need to take these techniques from bench to bedside.


Sign in / Sign up

Export Citation Format

Share Document