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Texas Attorney General Settles with Healthcare AI Firm Over False Claims on Product Accuracy and Safety

By Squire Patton Boggs on Posted in Artificial Intelligence, Digital Health
The Office of the Attorney General of Texas (“OAG”) announced a “first-of-its-kind healthcare generative AI” settlement with Pieces Technology, Inc. (“Pieces”). The settlement related to the Texas OAG allegations that Piece’s advertising and marketing claims about the accuracy of its generative artificial intelligence (GenAI) products in violation of the Texas Deceptive Trade Practices – Consumer Protection Act … Continue Reading

Singapore Consults on Groundbreaking Health Information Bill

By Charmian Aw on Posted in Data Protection, Digital Health, Singapore
On December 11, 2023, Singapore’s Ministry of Health launched a public consultation exercise on a proposed Health Information Bill (Bill), with a draft expected to be tabled in Parliament in the first half of 2024. Whilst extensive industry consultations have been conducted on the proposed provisions of the Bill involving 39 focus groups and over … Continue Reading

Singapore to Pass Comprehensive Health Data Law

By Charmian Aw on Posted in Cybersecurity, Data Protection, Digital Health, Singapore
On December 4, 2023, Singapore’s Ministry of Health (Ministry) announced that the nation’s first ever comprehensive health data law, the Health Information Bill (Bill), will be introduced in mid-2024. A set of Cyber & Data Security Guidelines for Healthcare Providers (Guidelines) was also published. Of particular importance is that these Guidelines will frame and eventually … Continue Reading

Singapore Updates Data Privacy Rules for Healthcare Sector

By Charmian Aw on Posted in Data Protection, Digital Health, Privacy
Nine years after its initial inception, Singapore’s data protection authority (Commission) published in September 2023 an updated set of advisory guidelines for the healthcare sector (Revised Guidelines). As with other advisory guidelines issued by the Commission, the Revised Guidelines are not intended to be legally binding, but will guide the interpretation and enforcement of Singapore’s … Continue Reading

Join us on September 28 for a Webinar on Washington’s My Health My Data Act and other Consumer Health Data Regulation

By Squire Patton Boggs on Posted in Data Protection, Digital Health
With its private right of action and expansive scope – extending far beyond Washington state’s borders and applying to a wide swath of health- and non-health-oriented companies alike – Washington’s My Health My Data Act is poised to be more ground-shifting than any other consumer privacy law that came before it. Join Kyle Fath, Bola … Continue Reading

Florida Electronic Health Records Exchange Act Amended – Health Records Maintained by Qualifying Health Care Providers Must Be Stored in the U.S., U.S. Territories, and Canada Only

By Julia Jacobson, John Wyand, Kimberly Donovan and Gicel Tomimbang on Posted in Data Protection, Digital Health, Electronic Health Records, Florida, HIPAA
On May 8, 2023, Governor Ron DeSantis of Florida signed CS/CS/SB 264, amending a suite of Florida statutes to impose heightened requirements on business activities involving foreign interests.  As related to the health care industry, CS/CS/SB 264 amended the Florida Electronic Health Records Exchange Act (“Act”) to, among other things, require “health care providers” that … Continue Reading

OCR Joins Chorus of Regulators Warning About Health Data Tracking Technology

By Julia Jacobson and Gicel Tomimbang on Posted in Compliance, Data Protection, Digital Health, HIPAA, Privacy, Publications, Technology
Key Takeaway: Organizations must conduct a fact-based analysis to determine whether health data collection and tracking technology deployed on their websites and mobile apps complies with the federal Health Insurance Portability and Accountability Act (“HIPAA”) and other applicable laws and guidance. Cookies, web beacons, and similar technology are used to collect and analyze data about … Continue Reading

Italian Ministers Announce Timetable for Investment in Digital Health

By Daniela Sabelli, Fabrizio Vismara, Francesco Liberatore and Squire Patton Boggs on Posted in Digital Health, Electronic Health Records, EU, Technology, Telehealth
On January 8, 2022, Minister of Health Roberto Speranza and Minister for Technological Innovation and Digital Transition Vittorio Colao, in an article published in the Italian press, made a number of announcements about the timing of the Italian government’s intended investment in digital health. This investment forms part of the Italian Recovery and Resilience Plan … Continue Reading

ONC Delays Timeframes for Information Blocking and Changes To Health IT Certification Program

By Kristin Bryan on Posted in Department of Health and Human Services, Digital Health, Technology
Last week, the Department of Health and Human Services (“HHS”) Office of the National Coordinator for Health Information Technology (“ONC”) announced an Interim Final Rule with Comment Period (“IFC”) delaying compliance dates and timeframes for information blocking and the health IT certification program. This delay will come as a welcome change for “Actors” (i.e., health … Continue Reading

Tips for Providers to Avoid Telehealth Compliance Risk

By Squire Patton Boggs on Posted in Compliance, COVID-19, Digital Health, Electronic Health Records
One of the more unanticipated consequences of the CoVID-19 pandemic is the rapid shift to telehealth by health care providers.  Before the surge of CoVID-19,  the Centers for Medicare and Medicaid Services (CMS) limited Medicare reimbursements for virtual services to a narrow set of circumstances, which typically still required the patient to leave his or … Continue Reading

Healthcare Cybersecurity Best Practices Out Now

By Squire Patton Boggs on Posted in Cybersecurity, Department of Health and Human Services, Digital Health
A new outlook on the most prominent cybersecurity threats in the healthcare industry today and a series of corresponding, risk-prioritized cybersecurity best practices to combat these threats are now available from the Department of Health and Human Services (HHS).  More than 150 private sector healthcare and cybersecurity experts contributed to this guidance as part of … Continue Reading

Digital Health Update: Recent FDA Cyber Initiatives

By Jennifer Tharp on Posted in Cybersecurity, Data Protection, Department of Health and Human Services, Digital Health, FDA, Life Sciences, Medical Device, Policy, Regulatory Compliance, Technology
The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading

FCC COMMENCES INQUIRY ON ESTABLISHING $100-MILLION TELEHEALTH PILOT PROGRAM

By John Wyand and Paul Besozzi on Posted in Digital Health, FDA, Policy, Telehealth
FCC COMMENCES INQUIRY ON ESTABLISHING $100M TELEHEALTH PILOT PROGRAM On August 2, 2018, The Federal Communications Commission has unanimously approved a Notice of Inquiry (“NOI”) to establish a $100-million  telehealth pilot program. FCC seeks to identify how the agency can “help advance and support the movement in telehealth towards connected care everywhere and improve access … Continue Reading

PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC

By John Wyand and Paul Besozzi on Posted in Digital Health, FCC, Policy, Technology, Telehealth
PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC Majority Of Federal Communications Commission (FCC) Supports 40%+ Annual Increase In Rural Health Care Program Funding – Following on a proposal to review annual funding for the FCC’s Rural Health Care Program (RHCP), which currently provides $400 million in annual subsidies for telecommunications … Continue Reading

Law360 Expert Analysis: Health Tech Is The New Focus For Cybersecurity Policy

By Squire Patton Boggs on Posted in Cybersecurity, Data Protection, Digital Health, Privacy, Technology
In a May 22, 2018 article that appeared in Law360 Expert Analysis piece, Squire Patton Boggs partner Elliot Golding writes, “There is no shortage of attention on health care data privacy and cybersecurity, with an avalanche of new and proposed government and regulatory initiatives underway. Although health care has long been a key target for … Continue Reading

New EU Strategy on Artificial Intelligence

By Wolfgang Maschek and Christina Economides on Posted in Cybersecurity, Data Protection, Digital Health, International Healthcare, Regulatory Compliance
On Wednesday 25 April, the EU Commission unveiled a new strategy to boost Europe’s capabilities and related industries around artificial intelligence. As you know, this is a “hot topic” that has the potential to affect many businesses and sectors across Europe and beyond. Many of our clients are very interested in this technology development (and … Continue Reading

CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29

By John Wyand on Posted in Department of Health and Human Services, Digital Health, Reimbursement, Technology
CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29 The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as … Continue Reading

Key Health Care Technology Privacy and Cybersecurity Considerations

By Squire Patton Boggs on Posted in Compliance, Cybersecurity, Data Protection, Digital Health, HIPAA, Medical Device, Privacy, Technology
In a podcast interview with Healthcare InfoSecurity, Squire Patton Boggs Partner Elliot Golding addresses evolving healthcare privacy and security issues, particularly complex issues involving Internet of Things (IoT) devices.  This includes addressing new risks when connected devices link to legacy systems, the applicable regulatory environment, and other key issues companies operating in the health care … Continue Reading

EU’s proposed eHealth measures focusing on broadening the availability and sharing of health data

By Wolfgang Maschek and Christina Economides on Posted in Cybersecurity, Data Protection, Digital Health, Regulatory Compliance
On 25 April 2018, the European Commission (EC) issued a Communication on enabling the digital transformation of healthcare, outlining the European Union’s (EU) priorities and actions towards digital health. The EU’s plan focuses on the following core priorities: Ensuring citizens’ access to their health data and introducing the possibility to share their data across borders; … Continue Reading
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