Tag: health care law

Software as a Medical Device: Challenges Facing the Industry

SaMD Blog Series: Introduction

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical devices. We will be addressing various considerations including technology, data, intellectual property, licensing, and contracting.

The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, SaMD need not be part of a physical device to achieve its intended purpose. For instance, SaMD could be an application on a mobile phone and not be connected to a physical medical device.

With the proliferation of SaMD also comes the need for those building and using it to firmly grasp legal and regulatory considerations to ensure successful use and commercialization. Over the next several weeks, we will be addressing some of more common issues faced by digital health companies, investors, innovators, and clinicians when developing, utilizing, or commercializing SaMD. The Food and Drug Administration (FDA) has already cleared a significant amount of SaMD, including more than 500 algorithms employing artificial intelligence (AI). Some notable examples include FDA-cleared SaMD such as wearable technology for remote patient monitoring; doctor prescribed video game treatment for children with ADHD; fully immersive virtual reality tools for both physical therapy and mental wellness; and end to end software that generates 3D printed models to better plan surgery and reduce operation time. With this rapid innovation comes a host of legal and regulatory considerations which will be discussed over the course of this SaMD Blog Series.

General Intellectual Property (IP) Considerations for SaMD

This edition will discuss the sophisticated IP strategies that can be used to protect innovations for the three categories of software for biomedical applications: SaMD, software in a medical device, and software used in the manufacture or maintenance of a medical device, including clinical trial collaboration and sponsored research agreements, filing patent applications, and pursuing other forms of protection, such as trade secrets.

Licensing and Contracting with Third Parties for SaMD

This edition will unpack engaging with third parties practically and comprehensively, whether in the context of (i) developing new SaMD or (ii) refining or testing existing SaMD. Data and IP can be effectively either owned or licensed, provided such licenses protect the future interests of the licensee. Such ownership and licensing are particularly important in the AI and machine learning space, which is one area of focus for this edition.

FDA Considerations for SaMD

This edition will explore how FDA is regulating SaMD, which will include a discussion of what constitutes a regulated device, legislative actions to spur innovation, and how FDA is approaching regulation of specific categories of SaMD such as clinical decision support software, general wellness applications, and other mobile medical devices. It will also examine the different regulatory pathways for SaMD and FDA’s current focus on Cybersecurity issues for software.

Health Care Regulatory and Reimbursement Considerations for SAMD

This edition will discuss the intersection of remote monitoring services and SaMD, prescription digital therapeutics and how they intersect with SaMD, licensure and distributor considerations associated with commercializing SaMD, and the growing trend to seek out device specific codes for SaMD.

Our hope is that this series will be a starting point for digital health companies, investors, innovators, and clinicians as each approaches development and use of SaMD as part of their business and clinical offerings.

© 2023 Foley & Lardner LLP

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EMTALA in the Post-Dobbs World

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.1 EMTALA, which was enacted in 1986 to address concerns about patient dumping, went unnoticed for many years, but has garnered heightened attention as a result of the COVID-19 pandemic, and more recently, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (Dobbs).2

EMTALA is a federal law and expressly preempts state laws with which it directly conflicts. After the Dobbs decision was officially published in June, a number of states implemented laws that prohibited or restricted access to reproductive care. Many of these laws include potential civil sanctions and criminal liability for healthcare providers offering or performing these services regardless of the circumstances, including emergency situations. The Biden Administration, in contrast, has taken action to preserve access to reproductive care through a number of executive and federal agency actions. These actions are intended by the federal government to apply in all states, including those states where restrictions have been put in place. Following this activity, litigation between the federal government and several states has ensued to address potential conflicts between federal laws requiring the provision of access and state laws that prohibit or restrict access to reproductive health services. A summary of the current EMTALA landscape is set forth below.

EMTALA Requirements

Under EMTALA, hospitals with emergency departments (EDs) must provide a medical screening examination to any individual who comes to the ED, regardless of insurance status. EMTALA prohibits hospitals with EDs from refusing to examine or treat individuals with an EMC. Upon provision of a medical screening examination, hospitals must provide necessary stabilizing treatment for EMCs and labor within the hospital’s capability. If the hospital is unable to properly treat or stabilize the patient, the hospital must provide an appropriate transfer to another medical facility.

Under EMTALA, an EMC includes “a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in:

(i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,

(ii) serious impairment to bodily functions, or

(iii) serious dysfunction of any bodily organ or part…”3

Many common pregnancy-related complications, such as preeclampsia or ectopic pregnancies, qualify as EMCs. However, certain state anti-abortion laws prohibit or criminalize abortions regardless of the existence of an EMC under federal law, which creates a potential conflict when an abortion is necessary to stabilize an EMC under EMTALA. As a result of this friction between state and federal law, EMTALA has received renewed attention at a federal and state level in recent months.

Executive Order on Protecting Access to Reproductive Healthcare Services

On July 8, 2022, after the Dobbs decision was officially issued, President Biden issued Executive Order 14076 (Executive Order), which directed the Department of Health and Human Services (HHS) to submit a report identifying steps to ensure all patients, including pregnant women and women experiencing pregnancy loss, receive the full protections offered by EMTALA. The Executive Order also directed HHS to consider updates to guidance on obligations under EMTALA.

CMS Memorandum and HHS Letter to Healthcare Providers

On July 11, 2022, in response to the Executive Order, CMS published a memorandum to State Survey Agency Directors to restate existing guidance for hospital staff and physicians in light of new state laws that prohibit or restrict access to abortion (Memorandum). The Memorandum reinforced CMS’ view that:

  • EMTALA mandates that all patients who come to a EDs and request examination or treatment must receive an appropriate medical screening examination, stabilizing treatment, and transfer regardless of any state law restrictions about specific procedures,

  • Only physicians and qualified medical personnel may make the determination of an EMC,

  • Hospitals should ensure that all staff who interact with patients presenting to the ED are aware of the hospital’s obligations under EMTALA,

  • Hospitals may not cite state law or practice as the basis for transfer,

  • Physicians’ professional and legal duties under EMTALA preempt any conflicting state law or mandate,

  • If a physician believes that abortion is the stabilizing treatment necessary to resolve an EMC, the physician must provide that treatment, and

  • State law is preempted by EMTALA when it prohibits abortion and does not include an exception for the life and health of the pregnant person or has a more restrictive definition of EMC.

The Memorandum also clarified that pregnant patients may experience EMCs including, but not limited to, ectopic pregnancy, complications of pregnancy loss, or emergent hypertensive disorders, such as preeclampsia with severe features and that stabilizing treatment encompasses both medical and surgical interventions, such as methrotrexate therapy or dilation and curettage.

The Secretary of HHS also published on July 11, 2022 a letter to healthcare providers reminding them of their obligation to provide stabilizing medical treatment to their pregnant patients in accordance with EMTALA, regardless of the state in which the provider practices (Letter). The Letter also reiterated that:

  • any state laws or mandates which employ a more restrictive definition of EMC are preempted by EMTALA statute, and

  • the course of necessary stabilizing treatment is under the physician’s or other qualified medical personnel’s purview.

The State of Texas Sues the Biden Administration

On July 14, 2022, the Texas Attorney General brought suit against HHS and CMS to challenge the Memorandum and Letter relating to federal law obligations for pregnant patients.4 The complaint alleged that EMTALA does not preempt state law when state law prohibits abortion and does not include an exception for the life of the pregnant person or draws the exception more narrowly than the definition of EMC under EMTALA. Specifically, Texas sought to enforce a state statute, the Human Life Protection Act, which would ban and criminalize abortions unless a woman “has a life-threatening physical condition arising from pregnancy that places her ‘at risk of death or poses a serious risk of substantial impairment of a major bodily function unless the abortion is performed”(emphasis added).5 The complaint also alleged that EMTALA does not require a healthcare provider to perform an abortion if it is the stabilizing treatment necessary to resolve an EMC. On August 23, 2022, the United States District Court for the Northern District of Texas (Lubbock Division) blocked enforcement of the Memorandum and Letter in the State of Texas on the basis that federal guidance did not preempt state law, exceeded the authority of EMTALA, and was issued without a proper notice and comment period. The Court found that, because EMTALA is silent regarding abortion and “how stabilizing treatments must be provided when a doctor’s duties to a pregnant woman and her unborn child possibly conflict,” “there is no direct conflict” between federal and Texas law with the end result that “EMTALA leaves it to the states”.6

The Biden Administration Sues the State of Idaho

On August 2, 2022, the Department of Justice (DOJ) sued the State of Idaho, alleging violation of EMTALA. Under Idaho’s proposed abortion law, which was slated to go into effect on August 25th, the performance of all abortions are criminalized regardless of the reason for which they may be performed including to prevent the death of the pregnant woman.7 Instead, the law permits physicians to raise two affirmative defenses to avoid criminal liability:

(i) The physician determined, in h/her good faith medical judgment and based on the facts known to the physician at the time, that the abortion was necessary to prevent the death of the pregnant woman, and

(ii) Prior to the performance of the abortion, the pregnant woman reported the act of rape or incest to a law enforcement agency and provided a copy of such report to the physician.8

The DOJ’s complaint alleged that  Idaho’s law does not provide a defense when the health of the pregnant patient is at stake, which is considered to fall within the definition of an EMC under EMTALA. In addition, the DOJ asserted that the fear of criminal prosecution may lead providers to avoid performing abortions even when it is a medically necessary treatment to prevent severe risk to the patient’s health. On August 24, 2022, the United States District Court for the District of Idaho found that Idaho’s law conflicted with EMTALA and granted the federal government a preliminary injunction blocking the enforcement of Idaho’s proposed abortion law.9 In contrast to the Northern District of Texas Court’s interpretation of the conflict between state law and EMTALA, the District Court of Idaho noted that found that Idaho’s criminal abortion statute deterred abortions given that it provided for an affirmative defense rather than an exception for the provision of emergency care and, therefore, obstructed EMTALA’s purpose.10

Looking to the Future

While EMTALA has been in place for decades, its applications in the post-Dobbs world continue to evolve and will be at the forefront in states with abortion restrictions, particularly where the scope of federal law obligations to provide stabilizing treatment for conditions that threaten the health of the pregnant patient conflict with state law exceptions or affirmative defenses.

The law, policy and regulatory climate surrounding the Dobbs decision is complex and quickly developing. The information included in this article is current as of writing, but it does not address all potential legal issues or jurisdictional differences, and the information presented may no longer be current. Readers should consult counsel regarding their specific situation.

FOOTNOTES

1 42 U.S.C. §1395dd.

2 For additional information regarding the Dobbs decision, please refer to the following resources: Supreme Court Decision in Dobbs v. Jackson Women’s Health Organization Overturns 50 Years of Precedent on Abortion Laws and Rights | Healthcare Law Blog (sheppardhealthlaw.com), WHLC Dobbs Series Part 1 Where are we now?: Sheppard Mullin Webinar.

3 42 U.S.C. §1395dd(e)(1).

4 State of Tex. v. Becerra, et al., No. 5:22-cv-185 (N.D. Tex. Jul. 14, 2022).

5 Tex. Health & Safety Code § 170A.

6 State of Tex. v. Becerra, et al., No. 5:22-cv-185 (N.D. Tex. Jul. 14, 2022), Memorandum Opinion and Order at 49.

7 Idaho Code § 18-622.

8  Idaho Code § 18-622(3).

9 U.S. v. Idaho, No. 1:22-cv-00329-BLW.

10 U.S. v. Idaho, No. 1:22-cv-00329-BLW, Memorandum Decision and Order at 26-31.

Article By Amy J. Dilcher and Arushi Pandya of Sheppard, Mullin, Richter & Hampton LLP

For more health and health law legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

Congress Awaits Health Provisions in President’s Budget

Health Bills Slated for House Floor Consideration; SAMHSA Releases Proposed Rule Focused on Confidentiality of Substance Use Disorder Patient Records

Legislative Activity

Congress Awaits Health Provisions in President’s Budget

On Tuesday, February 9, President Barack Obama will submit his FY 2017 Budget Request to Congress, which is expected to include several large-scale investments for the nation’s health. Last week, the White House released a “sneak preview” of the Budget, which includes: $755 million for cancer research as part of the “moonshot” to cure cancer; a legislative proposal to provide any state that takes up the Medicaid expansion option the same three years of full federal support that states that expanded in 2014 received; a commitment to changes in the excise tax on high-cost employer-sponsored health coverage, otherwise known as the “Cadillac Tax”; and $1 billion in mandatory funding over two years to address prescription drug abuse and heroin use.

On Wednesday, February 10, U.S. Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell will provide testimony on the Budget to the House Committee on Ways and Means. The next day, she will also address the Budget in her testimony to the Senate Committee on Finance.

Health Bills Slated for House Floor Consideration

House Majority Leader Kevin McCarthy (R-CA) has announced that several health care bills will be considered on the floor this week.

On Tuesday, the following pieces of health legislation are expected to be considered under suspension of the rules: H.R. 3016, the Veterans Employment, Education, and Healthcare Improvement Act, as amended, which clarifies the role of podiatrists in the Department of Veterans Affairs (VA); H.R. 3106, the Construction Reform Act of 2016, which makes certain changes in the administration of Department medical facility construction projects; H.R. 3262, To provide for the conveyance of land of the Illiana Health Care System of the Department of Veterans Affairs in Danville, Illinois; H.R. 4056, To authorize the Secretary of Veterans Affairs all right, title, and interest of the United States to the property known as “The Community Living Center” at Lake Baldwin Veterans Affairs Outpatient Clinic, Orlando, Florida, as amended; H.R. 4437, To extend the deadline for the submittal of the final report required by the Commission on Care; H.R. 3234, the VA Medical Center Recovery Act, which establishes within the VA an Office of Failing Medical Center Recovery; and H.R. 2915, the Female Veteran Suicide Prevention Act, which directs the Secretary of the VA to identify mental health care and suicide prevention programs that are effective in treating women veterans.

Later in the week, the House is expected to consider H.R. 2017, the Common Sense Nutrition Disclosure Act of 2015, which seeks to improve and clarify disclosure requirements for restaurants and other retail food establishments.

Senate HELP Committee to Mark Up Health Legislation

On Tuesday, February 9, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a markup to consider several health care bills. In January, Committee Chairman Lamar Alexander (R-TN) announced the Committee’s schedule for the “step by step” consideration of biomedical innovation bills. This process, aimed at legislation that is somewhat similar to language in the House-passed 21st Century Cures Act (H.R. 6), begins with this markup.

Legislation to be considered on Tuesday includes: S. 2030, the Advancing Targeted Therapies for Rare Diseases Act of 2015, which allows the sponsor of an application for the approval of a targeted drug to utilize data and information from the sponsor’s previously approved targeted drugs; S. 1622, the FDA Device Accountability Act of 2015, which requires the Food and Drug Administration (FDA) to ensure training on least burdensome requirements for employees who review premarket submissions of medical devices; S. 2014, the Next Generation Researchers Act, which seeks to demonstrate a commitment to our nation’s scientists by increasing opportunities for the development of future researchers; S. 800, the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act, which seeks to improve, coordinate, and enhance National Institutes of Health (NIH) rehabilitation research; S. 849, the Advancing Research for Neurological Diseases Act of 2015, which provides for systematic data collection and analysis and epidemiological research regarding neurological diseases; S. ___, the Preventing Superbugs and Protecting Patients Act; and S. ___, the Improving Health Information Technology Act.

This Week’s Hearings:

  • Tuesday, February 9: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a markup of health care bills, as described above.

  • Wednesday, February 10: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining Medicaid and CHIP’s Federal Medical Assistance Percentage.”

  • Wednesday, February 10: The House Committee on Veterans’ Affairs will hold a hearing titled “U.S. Department of Veterans Affairs Budget Request for Fiscal Year 2017.”

  • Wednesday, February 10: The House Committee on Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations and Subcommittee on the Western Hemisphere will hold a joint hearing titled “The Global Zika Epidemic: Emerging in the Americas.”

  • Wednesday, February 10: The House Committee on Ways and Means will hold a hearing titled “Department of Health and Human Services’ (HHS) Fiscal Year 2017 Budget Request.”

  • Wednesday, February 10: The House Committee on Rules will meet on H.R. 2017, the Common Sense Nutrition Disclosure Act of 2015.

  • Wednesday, February 10: The Senate Committee on the Judiciary will hold a hearing titled “Breaking the Cycle: Mental Health and the Justice System.”

  • Wednesday, February 10: The Senate Special Committee on Aging will hold a hearing which “will unveil and examine a new, troubling scam by global drug traffickers perpetrated against our nation’s seniors.”

  • Thursday, February 11: The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing titled “Choice Consolidation: Improving VA Community Care Billing and Reimbursement.”

  • Thursday, February 11: The House Committee on Homeland Security Subcommittee on Emergency Preparedness, Response, and Communications will hold a hearing titled “Improving the Department of Homeland Security’s Biological Detection and Surveillance Programs.”

  • Thursday, February 11: The Senate Committee on Finance will hold a hearing titled “The President’s Fiscal Year 2017 Budget.”

  • Thursday, February 11: The Senate Committee on the Judiciary will hold a markup, which will include consideration of: S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015, which seeks to improve enforcement efforts for prescription drug diversion and abuse; and S. 524, the Comprehensive Addiction and Recovery Act of 2015, which authorizes the Attorney General to award grants to address prescription opioid abuse and heroin use.

  • Friday, February 12: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “Outbreaks, Attacks, and Accidents: Combatting Biological Threats.”

Regulatory Activity

SAMHSA Releases Proposed Rule Focused on Confidentiality of Substance Use Disorder Patient Records

On Friday, February 5, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule titled “Confidentiality of Substance Use Disorder Patient Records.” The proposed rule seeks to amend the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, which were last substantively updated in 1987. According to HHS, the proposed rule will “facilitate health information exchange to support delivery system reform efforts” and ensure privacy for patients seeking substance use disorder treatment.

The proposed rule will be published in the Federal Register on February 9, and comments are due April 11.

Article By Beth L. Goldstein of Squire Patton Boggs (US) LLP
© Copyright 2016 Squire Patton Boggs (US) LLP

CMS’s Top 7 Changes to Stark Law

On November 16, 2015, the Department of Health and Human Services, Centers for Medicare and Medicaid Services, issued a final rule revising, clarifying, and adding exceptions to the Physician Self-referral Law (“Stark”) in order to (1) accommodate delivery and payment system reform; (2) reduce burdens; and (3) ensure and facilitate compliance. These changes include two new exceptions, clarifications adding additional explanations to existing policies, and revisions to existing definitions and exceptions.

Below are the top 7 changes providers and physicians should note:

  1. New “assistance to compensate a nonphysician practitioner (NPP)” exception: allows remuneration from a hospital, federally qualified health center, or rural health clinic to a physician to recruit a NPP, where substantially all (i.e., 75%) of the services furnished by the NPP to the patients of the physician’s practice are for primary care services or mental health care services. Please note this exception applies to the following NPPs: (1) physician assistants; (2) nurse practitioners; (3) clinical nurse specialists; (4) certified nurse midwives; (5) clinical social workers; and (6) clinical psychologists.

  2. New “timeshare arrangements” exception: this exception covers “use” arrangements only, which includes the use of premises, equipment (excluding advanced imaging equipment, radiation therapy equipment, and (most) clinical or pathology laboratory equipment), personnel, items, supplies, or services. Traditional office space leases and arrangements conveying a possessory leasehold interest in office space are not covered under this exception. Compensation for such arrangements must be carefully structured, as percentage compensation and per-unit services fees (i.e., “per-use” and “per-patient” rates) are prohibited but hourly or half day rates are acceptable.

  3. Clarification on the writing requirement: exceptions containing a writing requirement for certain compensation arrangements use “arrangement” and “agreement” interchangeably. The rule now clarifies that this requirement only requires an arrangement be set out in writing. Although CMS recommends having one signed written contract that satisfies every requirement of the exception, the preamble clarifies that this requirement may also be satisfied through a collection of documents that relate to one another and to the exact arrangement.

  4. Clarification on the 1-year term requirement for office space rental, equipment rental, and personal service arrangements exceptions: the final rule clarifies the arrangement itself must have a duration of at least one year, but a formal “term” provision in a contract is not required. Instead, the duration requirement can be shown through contemporaneous documents establishing the arrangement lasted for at least one year. However, if the arrangement was terminated during the first year, the parties must be able to show they did not enter into a new arrangement for the same space, equipment, or services during the first year.

  5. Clarification regarding “split bill” arrangements: “split bill” arrangements do not involve remuneration between physicians and designated health services (DHS) entities, for items or services such as examination rooms, nursing personnel, and supplies, “because the physician and DSH entity do not provide items, services, or other benefits to one another.” 80 Fed. Reg. 70,886, 71,321 (Nov. 16, 2015). However, outpatient departments billing a payor in one single bill will establish a compensation arrangement and must fit under an exception.

  6. Revision to “temporary noncompliance with signature” requirement: prior to this final rule, parties who inadvertently failed to comply with the signature requirement had 90 days to comply and others had 30 days. Now, there is a blanket 90 day period to comply with this requirement, regardless of whether the failure to obtain a signature was inadvertent or not.

  7. Indefinite holdover provisions: expired arrangements under the office space and equipment rental exceptions and the personal service arrangements exception can be “heldover” indefinitely rather than for only six months, provided the arrangement: (1) satisfies all of the requirements at the time of expiration; (2) continues on the same terms and conditions; and (3) continues to satisfy all of the requirements during the holdover. Current arrangements in a valid holdover under the current six month holdover provisions on January 1, 2016 may qualify for an indefinite holdover.

Article By

Bryna S. Hummel
Robert D. Nauman
John E. Wyand
Squire Patton Boggs (US) LLP

© Copyright 2015 Squire Patton Boggs (US) LLP