Tag: digital health

Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Governing Health Data for Research, Development, and Innovation: The Missteps of the European Health Data Space Proposal

The Petrie-Flom Center Staff Leave a comment

By Enrique Santamaría

Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union. Although well intentioned and thoroughly needed, there are aspects of the EHDS that require further debate, reconsiderations, and amendments. Clarity about what constitutes scientific research is particularly needed.

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Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

Minsoo Kwon Leave a comment

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

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Stethoscope with blue suitcase on a table with American flag as background.

Is a Federal Medical License Constitutional?

Timothy Bonis Leave a comment

By Timothy Bonis

Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize.

This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legislative approaches, and speculate on how the late Roberts Court might respond to reform attempts.

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Nov 22, 2019 Palo Alto / CA / USA - Close up of Amazon logo and Smile symbol at one of their corporate offices located in Silicon Valley, San Francisco bay area.

One Medical Acquisition: The Path Forward

The Petrie-Flom Center Staff Leave a comment

This piece has been adapted slightly from its original form, which was published at On the Flying Bridge on July 24, 2022.

By Michael Greeley

Last week’s $3.9 billion acquisition of One Medical (NASDAQ: ONEM) by Amazon triggered significant hyperventilating about the transformative and immediate impact of this transaction on the health care industry. Interestingly, Amazon’s market capitalization increased 1.4% or $18.3 billion on the day of the announcement, paying for the purchase a few times over. Undoubtedly there could be exciting near-term benefits for the 750,000 ONEM members as their Amazon Prime accounts are linked to their ONEM memberships, facilitating targeted Whole Food and Amazon Pharmacy coupons. But what we might expect to see over time is a provocative debate with powerful implications for how each of us manage the arc of our health care journeys.
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Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Toward a Broader Telehealth Licensing Scheme

The Petrie-Flom Center Staff Leave a comment

By Fazal Khan

Evidence generated during the first year the COVID-19 pandemic has called into question the need for many of the telehealth restrictions that were in effect prior to the pandemic.

The question many policymakers are asking now is: which of the telehealth regulatory waivers enacted during the pandemic should become permanent?

My forthcoming article proposes that the federal government use its spending power to incentivize states to adopt a de facto national telehealth licensing scheme through state-based mutual recognition of licensing and scope of practice reforms through a Medicaid program funding “bonus.”

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Expanded Reimbursement Codes for Remote Therapeutic Monitoring: What This Means for Digital Health

Adriana Krasniansky Leave a comment

By Adriana Krasniansky

New reimbursement codes for virtual patient monitoring may soon be incorporated into Medicare’s fee schedule, signaling the continued expansion and reach of digital health technologies catalyzed by the COVID-19 pandemic.

In July 2021, the Centers for Medicare & Medicaid Services (CMS) proposed adding a new class of current procedural terminology (CPT) codes under the category of “remote therapeutic monitoring” in its Medicare Physician Fee Schedule for 2022 — with a window for public comments until September 13, 2021. While this announcement may seem like a niche piece of health care news, it signals a next-phase evolution for virtual care in the U.S. health system, increasing access possibilities for patients nationwide.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Should We Regulate Direct-to-Consumer Health Apps?

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By Sara Gerke and Chloe Reichel

According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.

In this final installment of our In Focus Series on Direct-to-Consumer Health Apps, we asked our respondents to reflect on this largely unregulated space in health tech.

Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?

Read their answers below, and explore the following links for their responses to other questions in the series.

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Mitigating Bias in Direct-to-Consumer Health Apps

Sara Gerke Leave a comment

By Sara Gerke and Chloe Reichel

Recently, Google announced a new direct-to-consumer (DTC) health app powered by artificial intelligence (AI) to diagnose skin conditions.

The company met criticism for the app, because the AI was primarily trained on images from people with darker white skin, light brown skin, and fair skin. This means the app may end up over-or under-diagnosing conditions for people with darker skin tones.

This prompts the questions: How can we mitigate biases in AI-based health care? And how can we ensure that AI improves health care, rather than augmenting existing health disparities?

That’s what we asked of our respondents to our In Focus Series on Direct-to-Consumer Health Apps. Read their answers below, and check out their responses to the other questions in the series.

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Hand holding smartphone with colorful app icons concept.

Who Owns the Data Collected by Direct-to-Consumer Health Apps?

Sara Gerke Leave a comment

By Sara Gerke and Chloe Reichel

Who owns the data that are collected via direct-to-consumer (DTC) health apps? Who should own that data?

We asked our respondents to answer these questions in the third installment of our In Focus Series on Direct-to-Consumer Health Apps. Learn about the respondents and their views on data privacy concerns in the first installment of this series, and read their thoughts on consumer access to DTC health app data in the second installment.

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Should Users Have Access to Data Collected by Direct-to-Consumer Health Apps?

Sara Gerke Leave a comment

By Sara Gerke and Chloe Reichel

Should consumers have access to the data (including the raw data) that are collected via direct-to-consumer (DTC) health apps? What real-world challenges might access to this data introduce, and how might they be addressed?

In this second installment of our In Focus Series on Direct-to-Consumer Health Apps, that’s what we asked our respondents. Learn about the respondents and their views on data privacy concerns in the first installment of this series. Read on for their thoughts on whether and how consumers should gain access to the data that direct-to-consumer health apps collect.

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