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Key Takeaways | Global Perspectives on Data Sharing and Privacy

During this session, the panel discussed strategies and business considerations when addressing compliance with the wide array of data protection and privacy laws and regulations across the United States and abroad. The panel shared insights on compliance and monitoring strategies as well as best practices in working with internal stakeholders.

Session panelists:

  • Rebecca Daley, Esq., Senior Associate Counsel, Office of the General Counsel, University of Maryland Medical System
  • David Linestky, Senior Vice President, Life Sciences, Phreesia
  • Roshal Marshall, Managing Chief Counsel, Enterprise Data Privacy, Security and Technology Law, McKesson Corporation
  • Erik Phelps, Executive Vice President, Chief Administrative and Legal Officer, Tempus Labs, Inc.
  • Sharon Lamb, Partner, McDermott Will & Emery
  • Moderator: Amy Pimentel, Partner, McDermott Will & Emery

Top takeaways included:

  • Saying that the privacy landscape is “dynamic” is an understatement. The rapidly evolving landscape is challenging to operationalize, as many companies find that their lines of business operate under different (and often overlapping) areas of the regulatory framework.
  • As digital health solutions continue to be embedded in traditional health offerings, one challenge that lies ahead is the ability to “future proof” compliance strategies. It will be critical to remain flexible as future collaborations present opportunities for industry growth and development.
  • It is crucial for business leaders to understand their organization’s data collection, storage and sharing processes and how they want to leverage data as an asset. This knowledge is particularly important when designing data strategies, designing notices and consents, and leveraging contractual protections in current and future partnerships.



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Trending in Telehealth: June 6 – 12, 2023

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.

Trending in the past week:

  • Telehealth pilot programs

A CLOSER LOOK

Finalized Legislation & Rulemaking

  • Nebraska enacted LB 227, which amends the definition of the “practice of dietetics and nutrition” to include telehealth services.
  • Nebraska enacted LB 50, which requires the state court administrator to create a pilot program to use physical space and information technology resources within Nebraska courts to serve as points of access for virtual behavioral health services for individuals at court. The pilot program is intended to provide access to confidential, reliable and safe behavioral health treatment via telehealth for individuals involved with the criminal justice system as defendants, probationers or victims in criminal proceedings.
  • Nevada enacted AB 432, which amends state optometry laws to establish requirements for synchronous and asynchronous optometry telemedicine and remote patient monitoring in optometric practice. The law imposes an established patient requirement for certain optometric telemedicine services, meaning that an optometrist must have conducted an in-person “comprehensive evaluation” of the patient within two years before the date of the service. Exceptions to the comprehensive evaluation requirement include synchronous services where the performing optometrist has access to records of a comprehensive examination conducted by another optometrist and certain limited asynchronous evaluations solely to determine whether a comprehensive evaluation is necessary. The law permits optometrists with out-of-state licenses to conduct the limited asynchronous services without a Nevada license. Finally, the law specifically imposes the comprehensive exam requirement with respect to patients who are located outside of the state and are treated by optometrists licensed in Nevada.
  • Oregon enacted SB 232, which allows out-of-state physicians or physician assistants who are not licensed in Oregon to provide care to patients located in Oregon, specifically when the out-of-state physician or physician assistant has established a provider-patient relationship with the patient in Oregon temporarily for the purpose of business, education, vacation or work and such patient requires direct medical treatment by the out-of-state physician or physician assistant. Out-of-state physicians or physician assistants may also provide care for patients with whom they have an established provider-patient relationship to provide temporary or intermittent follow-up. The law further clarifies that the practice of medicine using telemedicine occurs where patient is physically located.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

  • Connecticut progressed SB 1075 in the second chamber. The legislation would require the state’s Department of Public Health to establish, in collaboration with a hospital in the state, a Hospice Hospital at Home pilot program to provide hospice care to patients in the home through a combination of in-person visits and telehealth. If passed, the law would require the Department of Public Health to create [...]

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Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” or HTI-1.

HTI-1 includes proposals that would create new transparency and risk management expectations for artificial intelligence (AI) and machine learning (ML) technology that aid decision-making in healthcare. Importantly, ONC’s proposal includes requirements for a broad set of technologies based on algorithms or models that could be used by many types of users, for any purpose, irrespective of the technology’s risk profile and regardless of who developed the algorithm or model. If finalized, ONC’s HTI-1 proposal for AI/ML technologies they define as “Predictive Decision Support Interventions” will significantly impact the development, deployment and use of AI/ML tools in healthcare. As of June 14, 2023, comments on the HTI-1 proposed rule are due on June 20, 2023.

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Trending in Telehealth: May 31 – June 5, 2023

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate the delivery of virtual care.

Trending in the past week:

  • Interstate Compacts
  • Medical Cannabis
  • Mental Health

A CLOSER LOOK

Finalized Legislation & Rulemaking

  • Iowa enacted HF 671, adopting the Professional Counselors Licensure Compact.
  • Minnesota enacted HF 100, permitting the medical sale and use of cannabis through the state’s registry program. HF 100 permits remote pharmacist consultations by secure videoconference, telephone or other remote means, as long as the pharmacist engaging in the consultation is able to confirm the identity of the patient and the consultation adheres to patient privacy requirements that apply to healthcare services delivered through telemedicine. A Minnesota licensed physician, physician assistant or advanced practice registered nurse (APRN) must determine on a yearly basis if the patient continues to have a qualifying medical condition for enrollment on the Division of Medical Cannabis registry.
  • Missouri passed a final rule establishing the Telehealth Dental Pilot Project for Medically Underserved Populations to examine new methods of extending dental care to residents in assisted living facilities, intermediate care facilities, residential care facilities and skilled nursing facilities, and homebound special needs patients. This rule permits the supervision of dental assistants and dental hygienists using telehealth technology.
  • Oklahoma enacted SB 12, creating a mental health transport revolving fund for the Department of Mental Health and Substance Abuse Services. This law permits telemedicine assessments of patients when assessments are requested by sheriffs or peace officers. The state’s criminal code defines the term peace officer as “any sheriff, police officer, federal law enforcement officer, tribal law enforcement officer, or any other law enforcement officer whose duty it is to enforce and preserve the public peace.” Okla. Stat. tit. 21 § 99.
  • Vermont enacted three telehealth-related laws:
    • H 62 adopts the Interstate Counseling Compact to facilitate interstate practice of licensed professional counselors with the goal of improving public access to professional counseling services.
    • H 86 adopts the Audiology and Speech-Language Pathology Interstate Compact, which streamlines the licensure process for audiologists and speech-language pathologists and allows the use of telehealth technology to facilitate increased access to audiology and speech-language pathology services.
    • H 282 adopts the Psychology Interjurisdictional Compact, which regulates the day-to-day practice of telepsychology and streamlines the licensure process for psychologists.

Legislation & Rulemaking Activity in Proposal Phase

Highlights:

  • Connecticut progressed HB 6768, which would permit physicians, APRNs and physician assistants to certify a qualifying patient’s use of medical marijuana and provide follow-up care using telehealth if they comply with other statutory certification and recordkeeping requirements.
  • Louisiana progressed two bills:



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Introducing McDermott’s AI in Healthcare Resource Center

Stay up-to-date and in-the-know on the surge of developments impacting AI in healthcare.

Our global, cross-practice team has curated links to key AI-related resources from legislative and executive bodies, government agencies and industry stakeholders in one easy-access location to help you stay current and engage in the AI conversation. We will continuously update this page as new developments emerge.
You will find:

  • Opportunities for public comment from lawmakers and government agencies to help you shape AI policy
  • Healthcare-specific policy and regulatory initiatives and legislative activity to watch
  • Frameworks, playbooks, whitepapers, blogs and more from key stakeholders
  • Insights and analysis from McDermott’s global healthcare, privacy and health policy leaders

Access now and subscribe for updates. 




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Trending in Telehealth: May 23 – 30, 2023

Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate virtual care.
Trending in the past week:

  • Forensic Examinations
  • Telehealth Flexibilities

A CLOSER LOOK
Finalized Legislation and Rulemaking

  • Florida passed legislation (SB 218) amending Fla. Stat. Ann. § 456.47 to revise the definition of “telehealth provider” to include persons licensed as genetic counselors. By way of background, in 2021, the Florida legislature created a new licensed and regulated profession—genetic counseling. SB 218 is likely one of several pieces of legislation that will incorporate the newly created profession into existing regulatory frameworks.
  • Minnesota enacted legislation (SF 2744) allowing telehealth to factor into the network adequacy assessments required to be performed by health carriers under Minnesota’s insurance laws. Minnesota also enacted appropriations legislation (SF 2995) that, among other things, allocates money for a study of telehealth expansion and payment parity in 2024.
  • Nevada passed legislation (AB 276) amending Nev. Rev. Stat. § 629.515 to authorize a provider who is conducting certain forensic medical examinations on an apparent victim of sexual assault or strangulation to use telehealth to connect to an appropriately trained physician, physician assistant or registered nurse to obtain instructions and guidance on conducting the examination.
  • West Virginia’s legislation requiring hospitals to have a trained healthcare provider available, or transfer agreement as provided in a county plan, to complete a sexual assault forensic examination (SB 89) became effective May 21, 2023, 90 days after its passage. “Available” includes having access to a trained sexual assault forensic examination expert via telehealth.

Legislation and Rulemaking Activity in Proposal Phase
Highlights:

  • Illinois progressed legislation (SB 2123) in the second chamber that would adopt the Counseling Compact.
  • Texas continued to progress legislation (HB 1771) in the second chamber that would require that each agency with regulatory authority over a health professional providing a telemedicine medical service, teledentistry or telehealth to adopt rules necessary to standardize formats for and retention of records related to a patient’s consent to treatment, data collection and data sharing.
  • Texas also progressed legislation (HB 617) in the second chamber that would establish a pilot project to provide emergency medical services instruction and emergency prehospital care instruction through a telemedicine medical service or telehealth service provided by regional trauma resource centers to healthcare providers in rural trauma facilities and emergency medical services providers in rural areas.

Why it matters:

  • Telehealth capabilities can reduce disparities in forensic examinations. States continue to progress legislation aiming to decrease disparities in the quality of forensic examinations by providing expert, live, interactive quality control and evidence-based methodologies to less experienced providers. Proponents argue that partnering on-site staff with telehealth [...]

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Top Takeaways | Successfully Deploying Digital Health in Value-Based Care

In this session from the Value-Based Care Symposium 2023, McDermott Will & Emery Partner Lisa Mazur moderated a panel that explored how digital health tools can support financial and clinical success under value-based care arrangements. Panelists also looked at how digital health companies can successfully demonstrate value within the value-based care framework and make themselves attractive partners to value-based care companies. The panel showcased perspectives from executives at digital health companies and companies participating in value-based care models that have successfully leveraged digital health tools.

Access the full takeaway here.




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Trending in Telehealth: May 16 – 22, 2023

Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate virtual care.

Trending in the past week:

  • Interstate Compacts
  • Telehealth Flexibilities

A CLOSER LOOK

Finalized Legislation & Rulemaking

  • The North Carolina General Assembly voted to override Gov. Roy Cooper’s veto of SB 20. Dubbed the Care for Women, Children, and Families Act, SB 20 operates to reduce access to reproductive health services, including by eliminating the provider’s ability to give patients information contained in the relevant consent form over the telephone. The legislation takes effect July 1.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

  • Alaska progressed legislation (SB 75) in the first chamber to join the Audiology and Speech-Language Pathology Interstate Compact.
  • Illinois progressed legislation (SB 2123) in the first chamber to adopt the Counseling Compact.
  • Oregon progressed legislation (SB 232) that would update the Oregon Medical Board’s telemedicine regulations at 52 O.R.S. §§ 677.080 and 677.137 to clarify that the practice of medicine occurs where a patient is physically located.
  • Texas continued to progress legislation (HB 1771) that would require each agency with regulatory authority over a health professional providing a telemedicine, teledentistry or telehealth to adopt rules to standardize formats for and retention of records related to a patient’s consent to treatment, data collection and data sharing.
  • Texas also progressed legislation (HB 617) in the first chamber that would establish a pilot project to provide emergency medical and prehospital care instruction through telemedicine/telehealth services by regional trauma resource centers to healthcare providers in rural area trauma facilities.

Why it matters:

  • Interstate compact adoption remains elevated. States continue to progress legislation that would enact licensure compacts across healthcare professions. This week, Alaska and Illinois took steps to adopt compacts that would ease out-of-state licensure hurdles and improve shared systems across public agencies.
  • Texas addresses rural care via telehealth. Many states are progressing legislation that would permanently extend telehealth flexibilities to allow providers to practice across counties and use technologies to reach and educate patients in rural low-access areas.

Telehealth is an important development in care delivery, but the regulatory patchwork is complicated. The McDermott digital health team works alongside the industry’s leading providers, payors and technology innovators to help them enter new markets, break down barriers to delivering accessible care and mitigate enforcement risk through proactive compliance. Are you working to make healthcare more accessible through telehealth? Let us help you transform telehealth.




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Trending in Telehealth: May 8 – 15, 2023

Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate virtual care.

Trending in the past week:

  • Inmate Health
  • Interstate Compacts

A CLOSER LOOK

Finalized Legislation and Rulemaking

Highlights:

  • Florida enacted legislation, HB 267, eliminating the explicit exclusion of audio-only telephone calls from the definition of telehealth in Florida’s telehealth practice standards. Accordingly, telephones are now a permitted telecommunications technology to provide telehealth services in Florida. Sponsored by Representative Fabricio, the bill passed the Florida Legislature unanimously and will take effect on July 1, 2023.
  • Vermont, in response to the US Supreme Court’s decision in Dobbs, enacted the Shield Bill, S 37, providing protections to patients and providers that receive or administer abortion and gender-affirming care.

Legislation and Rulemaking Activity in Proposal Phase

Highlights:

  • Iowa sent legislation to the governor, HF 671, that would establish the Professional Counselors Licensure Compact for professional counselors.
  • Louisiana progressed legislation, SB 186, that would allow Louisiana to join the Occupational Therapy Licensure Compact.
  • Missouri progressed legislation in the Second Chamber, SB 70, that would adopt the interstate Counseling Compact for professional counselors.
  • Texas progressed legislation, HB 3739/SB 1146, that would combine resources from the Department of Corrections and the University of Texas and Texas Tech University Health Sciences Center to explore ways to increase opportunities and expand access to telehealth-delivered services in correctional facilities.
  • Vermont progressed legislation, H 86/H 62, that would establish the Audiology & Speech-Language Pathology Interstate Compact and the interstate Counseling Compact for professional counselors.

Why it matters:

  • States continue to adopt interstate compacts. Well into the legislative session, states continue to introduce and progress legislation that would enact licensure compacts across healthcare professions. Just this week, Iowa, Louisiana, Missouri and Vermont took steps to adopt compacts that will improve continuity of care when clients or professionals travel, create a shared licensure data system, and protect public integrity by allowing the rapid sharing of investigative and disciplinary information.
  • Texas addresses inmate care via telehealth. The proposed legislation in Texas indicates the state’s desire to turn to telemedicine to provide healthcare services to individuals incarcerated in Texas prisons and jails. Proponents argue that increasing access to care for inmates via telemedicine reduces costs and improves outcomes.

Telehealth is an important development in care delivery, but the regulatory patchwork is complicated. The McDermott digital health team works alongside the industry’s leading providers, payors and technology innovators to help them enter new markets, break down barriers to delivering accessible care and mitigate enforcement risk through proactive compliance. Are you working to make healthcare more accessible through telehealth? Let us help you transform telehealth.




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HHS OIG Develops Toolkit to Analyze Telehealth Claims to Assess Program Integrity Risks

On April 20, 2023, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) released a new toolkit designed to help analyze telehealth claims to assess federal healthcare program integrity risks. The toolkit is OIG’s latest action in its continued focus on telehealth services that OIG considers to be high risk. The toolkit is based on methodologies highlighted in OIG’s September 2022 data brief, which identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity based on a review of Medicare fee-for-service claims data and Medicare Advantage data from March 1, 2020, through February 28, 2021 (OIG Data Brief). The September 2022 OIG Data Brief is discussed in detail in this prior On The Subject article.

OIG intends for the toolkit to be used by public and private parties, including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units, and other federal healthcare agencies to analyze program integrity risks and identify providers whose billing may pose a high risk and warrant further scrutiny.

Read more here. 




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