Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping.

BACKGROUND: The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. OBJECTIVE: This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. METHODS: We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. RESULTS: Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health-specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. CONCLUSIONS: Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

Building the Business Case for an Inclusive Approach to Digital Health Measurement With a Web App (Market Opportunity Calculator): Instrument Development Study.

BACKGROUND: The use of digital health measurement tools has grown substantially in recent years. However, there are concerns that the promised benefits from these products will not be shared equitably. Underserved populations, such as those with lower education and income, racial and ethnic minorities, and those with disabilities, may find such tools poorly suited for their needs. Because underserved populations shoulder a disproportionate share of the US disease burden, they also represent a substantial share of digital health companies' target markets. Incorporating inclusive principles into the product development process can help ensure that the resulting tools are broadly accessible and effective. In this context, inclusivity not only maximizes societal benefit but also leads to greater commercial success. OBJECTIVE: A critical element in fostering inclusive product development is building the business case for why it is worthwhile. The Digital Health Measurement Collaborative Community (DATAcc) Market Opportunity Calculator was developed as an open-access resource to enable digital health measurement product developers to build a business case for incorporating inclusive practices into their research and development processes. METHODS: The DATAcc Market Opportunity Calculator combines data on population demographics and disease prevalence and health status from the US Census Bureau and the US Centers for Disease Control and Prevention (CDC). Together, these data are used to calculate the share of US adults with specific conditions (eg, diabetes) falling into various population segments along key "inclusion vectors" (eg, race and ethnicity). RESULTS: A free and open resource, the DATAcc Market Opportunity Calculator can be accessed from the DATAcc website. Users first select the target health condition addressed by their product, and then an inclusion vector to segment the patient population. The calculator displays each segment as a share of the overall US adult population and its share specifically among adults with the target condition, quantifying the importance of underserved patient segments to the target market. The calculator also estimates the value of improvements to product inclusivity by modeling the downstream impact on the accessible market size. For example, simplifying prompts on a hypertension-focused product to make it more accessible for adults with lower educational attainment is shown by the calculator to increase the target market by 2 million people and the total addressable market opportunity by US $200 million. CONCLUSIONS: Digital health measurement is still in its infancy. Now is the time to establish a precedent for inclusive product development to maximize societal benefit and build sustainable commercial returns. The Market Opportunity Calculator can help build the business case for "why"-showing how inclusivity can translate to financial opportunity. Once the decision has been made to pursue inclusive design, other components of the broader DATAcc toolkit for inclusive product development can support the "how."

Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring.

In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern market access are often evolving slowly, sometimes creating market barriers. This article gives a brief overview of the existing clinical studies regarding the use of smart wearables in cardiac monitoring and provides insight into the main regulatory and legal aspects that need to be considered when such products are intended to be used in a health care setting. Based on this brief overview, the article elaborates on the specific requirements in the main areas of authorization/certification and reimbursement/compensation, as well as data protection and data security. Three case studies are presented as examples of specific market access procedures: the USA, Germany, and Belgium. This article concludes that, despite the differences in specific requirements, market access pathways in most countries are characterized by a number of similarities, which should be considered early on in product development. The article also elaborates on how regulatory and legal requirements are currently being adapted for digitally driven wearables and proposes an ongoing evolution of these requirements to facilitate market access for beneficial medical technology in the future.

Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials.

OBJECTIVES: In an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of 'virtual' clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic. DESIGN: We applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials. SETTING: All trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021. OUTCOME MEASURES: The primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019-February 2020) compared with the 10 months following (May 2020-February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants). RESULTS: CDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19. CONCLUSIONS: These findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants' COVID-19 diagnosis.

Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users.

Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide. Against this backdrop, many look to the expanding market for biosimilars-follow-on products to biologic drugs-as a vehicle for controlling pharmaceutical spending. This study explores the early years of entry of biosimilars and related follow-on products in the US. Using monthly sales data from the period 2005-19 for ten drug classes, we examine how quickly biosimilars/follow-on products gained market share and the subsequent trajectory of prevailing (national average invoice) prices. Our analysis suggests that although uptake has been slower than what is typically seen in generic drug markets, the most recent entrants have captured market share more rapidly than comparable earlier biosimilars/follow-on products. We also document that from biosimilar/follow-on products' time of entry, their lower prices help offset the overall trend in average annual reference-product price increases. Our findings can provide insight into future policy reforms aimed at increasing competition and use of biosimilars, leading to expanded patient access and significant cost savings.

Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study.

BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize the categorization of these apps to allow for efficient yet robust regulation is growing. However, regulators and researchers are faced with numerous challenges, as apps have a wide variety of features, constant updates, and fluid use cases for consumers. As past regulatory efforts have failed to match the rapid innovation of these apps, the US Food and Drug Administration (FDA) has proposed that the Software Precertification (Pre-Cert) Program and a new risk-based framework could be the solution. OBJECTIVE: This study aims to determine whether the risk-based framework proposed by the FDA's Pre-Cert Program could standardize categorization of top health apps in the United States. METHODS: In this quality improvement study during summer 2019, the top 10 apps for 6 disease conditions (addiction, anxiety, depression, diabetes, high blood pressure, and schizophrenia) in Apple iTunes and Android Google Play Store in the United States were classified using the FDA's risk-based framework. Data on the presence of well-defined app features, user engagement methods, popularity metrics, medical claims, and scientific backing were collected. RESULTS: The FDA's risk-based framework classifies an app's risk by the disease condition it targets and what information that app provides. Of the 120 apps tested, 95 apps were categorized as targeting a nonserious health condition, whereas only 7 were categorized as targeting a serious condition and 18 were categorized as targeting a critical condition. As the majority of apps targeted a nonserious condition, their risk categorization was largely determined by the information they provided. The apps that were assessed as not requiring FDA review were more likely to be associated with the integration of external devices than those assessed as requiring FDA review (15/58, 26% vs 5/62, 8%; P=.03) and health information collection (24/58, 41% vs 9/62, 15%; P=.008). Apps exempt from the review were less likely to offer health information (25/58, 43% vs 45/62, 72%; P<.001), to connect users with professional care (7/58, 12% vs 14/62, 23%; P=.04), and to include an intervention (8/58, 14% vs 35/62, 55%; P<.001). CONCLUSIONS: The FDA's risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health.

Association of the Meaningful Use Electronic Health Record Incentive Program With Health Information Technology Venture Capital Funding.

Importance: Although the Health Information Technology for Economic and Clinical Health (HITECH) Act has accelerated electronic health record (EHR) adoption since its passage, clinician satisfaction with EHRs remains low, and the association of HITECH with health care information technology (IT) entrepreneurship has remained largely unstudied. Objective: To determine whether the passage of the HITECH Act was associated with an increase in key measures of health care IT entrepreneurship. Design, Setting, and Participants: This economic evaluation of venture capital (VC) activity in the US from 2000 to 2019 examined funding trends in health care IT, EHR-related companies, and all VC investments before and after the passage of HITECH. A difference-in-differences analysis compared investments in health care IT companies with those of companies in 3 categories: general health care (non-IT), IT (non-health care), and all US VC transactions. Data were analyzed from September 2018 to August 2019. Exposures: Venture capital funding received by US companies before and after the HITECH Act. Main Outcomes and Measures: Venture capital investment in health care IT companies and the proportion of those investments going to seed-stage companies, a proxy for very early-stage entrepreneurship and innovation. Results: The data included 70 982 investments, of which 9425 (13.3%) were seed stage, 10 706 (15.1%) were early stage, and 50 851 (71.6%) were growth stage. After passage of the HITECH Act, investment in both health care IT companies and EHR-related companies increased at a rate much faster (13.0% and 11.4%, respectively) than VC as a whole (6.9%). In addition, the proportion of investments going to seed-stage health care IT companies increased compared with both overall VC investments and non-IT health care investments. Health care IT companies saw increased probabilities of transactions being seed-stage of 5.1% (SE, 2.2%; 95% CI, 0.8% to 9.3%; P = .02) compared with the entire sample of VC transactions and 13.6% (SE, 1.9%; 95% CI, 9.9% to 17.2%; P < .001) compared with non-IT health care VC transactions. Health care IT had essentially 0 increased probability of a transaction being seed stage compared with IT companies outside health care (-0.8% probability; SE, 2.4%; 95% CI, -5.4% to 3.9%; P = .75). Conclusions and Relevance: Although widespread clinician dissatisfaction with EHR systems remains a challenge, the HITECH Act's incentive program may have catalyzed early-stage entrepreneurship in health care IT, suggesting an important role for incentives in promoting innovation.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Regulatory oversight, causal inference, and safe and effective health care machine learning.

In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging actively in thinking about how best to facilitate safe and effective use. Although the scope of its oversight for software-driven products is limited, if FDA takes the lead in promoting and facilitating appropriate applications of causal inference as a part of ML development, that leadership is likely to have implications well beyond regulated products.

Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.

The use of biomarkers holds great promise for the development of new therapeutics and the acceleration of clinical research. However, biomarkers must be validated - a complex and costly endeavor. Importantly, biomarker validation is meaningfully shaped by economic and policy-driven incentives.

Cybersecurity features of digital medical devices: an analysis of FDA product summaries.

OBJECTIVES: To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices. DESIGN: We analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information. SETTING: The full set of regulated medical devices, approved over the years 2002-2016 included in the FDA's 510(k) and premarket approval databases. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas. RESULTS: Among regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%. CONCLUSIONS: To ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.

Physician Beliefs and Patient Preferences: A New Look at Regional Variation in Health Care Spendingf.

There is considerable controversy about the causes of regional variations in health care expenditures. Using vignettes from patient and physician surveys linked to fee-for-service Medicare expenditures, this study asks whether patient demand-side factors or physician supply-side factors explain these variations. The results indicate that patient demand is relatively unimportant in explaining variations. Physician organizational factors matter, but the most important factor is physician beliefs about treatment. In Medicare, we estimate that 35 percent of spending for end-of-life care and 12 percent of spending for heart attack patients (and for all enrollees) is associated with physician beliefs unsupported by clinical evidence. (JEL D83, H75, I11, I18).

Innovation under Regulatory Uncertainty: Evidence from Medical Technology.

This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34 percent (7.2 months) longer than follow-on entrants in regulatory approval. Back-of-the- envelope calculations suggest that the cost of a delay of this length is upwards of 7 percent of the total cost of bringing a new high-risk device to market. Considering potential explanations, I find that approval times are largely unrelated to technological novelty, but are meaningfully reduced by the publication of objective regulatory guidelines. Finally, I consider how the regulatory process affects small firms' market entry patterns and find that small firms are less likely to be pioneers in new device markets, a fact consistent with relatively higher costs of doing so for more financially constrained firms.

Review times and adverse events for cardiovascular devices.

Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.

Evaluating the impact of the Baby-Friendly Hospital Initiative on breast-feeding rates: a multi-state analysis.

OBJECTIVE: To evaluate the impact of the Baby-Friendly Hospital Initiative (BFHI) on breast-feeding initiation and duration overall and according to maternal education. DESIGN: Quasi-experimental study using data from five states (Alaska, Maine, Nebraska, Ohio, Washington) that participated in the Pregnancy Risk Assessment Monitoring System from 1999 to 2009. Using differences-in-differences models that included year and hospital fixed effects, we compared rates of breast-feeding initiation and duration (any and exclusive breast-feeding for ≥4 weeks) before and after BFHI accreditation between mothers who gave birth in hospitals that were accredited or became accredited and mothers from matched non-BFHI facilities. We stratified analyses into lower and higher education groups. SETTING: Thirteen BFHI hospitals and nineteen matched non-BFHI facilities across five states in the USA. SUBJECTS: Mothers (n 11 723) who gave birth in BFHI hospitals and mothers (n 13 604) from nineteen matched non-BFHI facilities. RESULTS: Although we did not find overall differences in breast-feeding initiation between birth facilities that received BFHI accreditation compared with non-Baby-Friendly facilities (adjusted coefficient = 0·024; 95 % CI -0·00, 0·51), breast-feeding initiation increased by 3·8 percentage points among mothers with lower education who delivered in Baby-Friendly facilities (P = 0·05), but not among mothers with higher education (adjusted coefficient = 0·002; 95 % CI -0·04, 0·05). BFHI accreditation also increased exclusive breast-feeding for ≥4 weeks by 4·5 percentage points (P = 0·02) among mothers with lower education who delivered in BFHI facilities. CONCLUSIONS: By increasing breast-feeding initiation and duration among mothers with lower education, the BFHI may reduce socio-economic disparities in breast-feeding.

Compliance with the Baby-Friendly Hospital Initiative and impact on breastfeeding rates.

OBJECTIVES: To examine compliance with the Baby-Friendly Hospital Initiative (BFHI) as well as evaluate the BFHI and its components on breastfeeding initiation and duration overall and according to maternal education level. DESIGN: Quasi-experimental study using data from the Pregnancy Risk Assessment Monitoring System (PRAMS) from 2004 to 2008. SETTING: Birth facilities in Maine. PARTICIPANTS: 915 mothers who gave birth in four hospitals that were BFHI-accredited or became accredited and 1099 mothers from six matched non-BFHI facilities. Mothers reported on seven (of 10) BFHI practices (breastfeeding practice score 0-7) and receipt of a gift pack with formula (yes/no). MAIN OUTCOME MEASURES: Self-report of breastfeeding initiation, any breast feeding for ≥4 weeks, exclusive breast feeding for ≥4 weeks. RESULTS: 34.6% of mothers from BFHI-accredited facilities reported experiencing all seven BFHI breastfeeding practices, while 28.4% reported being given a gift pack with formula. Among mothers with lower education, the BFHI increased breastfeeding initiation by 8.6 percentage points (adjusted coefficient, 0.086 [95% CI, 0.01 to 0.16]) and, independently, each additional breastfeeding practice was associated with an average increase in breastfeeding initiation of 16.2 percentage points (adjusted coefficient, 0.162 [95% CI, 0.15 to 0.18]). Among all mothers and mothers with higher education, there was no effect of the BFHI on breastfeeding rates. CONCLUSIONS: Compliance with BFHI practices among BFHI-accredited facilities is not optimal and needs to be monitored, as greater compliance may have an even larger impact on breastfeeding rates and potentially reduce socio-economic disparities in breast feeding.

Do state breastfeeding laws in the USA promote breast feeding?

OBJECTIVES: Despite the passage of state laws promoting breast feeding, a formal evaluation has not yet been conducted to test whether and/or what type of laws may increase breast feeding. The enactment of breastfeeding laws in different states in the USA creates a natural experiment. We examined the impact of state breastfeeding laws on breastfeeding initiation and duration as well as on disparities in these infant feeding practices. METHODS: Using data from the Pregnancy Risk Assessment Monitoring System, we conducted differences-in-differences models to examine breastfeeding status before and after the institution of laws between 2000 and 2008 among 326 263 mothers from 32 states in the USA. For each mother, we coded the presence of two types of state breastfeeding laws. Mothers reported whether they ever breast fed or pumped breast milk (breastfeeding initiation) and, if so, how long they continued. We defined breastfeeding duration as continuing to breast feed for ≥4 weeks. RESULTS: Breastfeeding initiation was 1.7 percentage points higher in states with new laws to provide break time and private space for breastfeeding employees (p=0.01), particularly among Hispanic mothers (adjusted coefficient 0.058). While there was no overall effect of laws permitting mothers to breast feed in any location, among Black mothers we observed increases in breastfeeding initiation (adjusted coefficient 0.056). Effects on breastfeeding duration were in the same direction, but slightly weaker. CONCLUSIONS: State laws that support breast feeding appear to increase breastfeeding rates. Most of these gains were observed among Hispanic and Black women and women of lower educational attainment suggesting that such state laws may help reduce disparities in breast feeding.