Developers of mobile applications for healthcare and fitness must identify and negotiate a diverse array of federal and state laws, regulations and rulings when designing and deploying their apps.
Since figuring out which federal rules apply often proves challenging, the Federal Trade Commission (FTC) in conjunction with the HHS Office for Civil Rights (OCR), the HHS Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA) maintain and have just updated the Mobile Health App Interactive Tool intended to help developers of health-related mobile apps understand when and federal laws and regulations might apply.
While not covering all relevant legal risks, the guidance tool does highlight certain key regulatory concerns by asking developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance tool points the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the 21st Century Cures Act and ONC Information Blocking Regulations.
Using the tool can help to clarify the potential applicability of these rules to a proposed app and help focus the developer on issues to consider regarding these laws as they design in administer their apps. Running through the tool also could help reduce legal fees and other consulting anniversary costs by helping developers of these apps gather helpful information and be more prepared to participate in informed manner when working with the legal team on their compliance. Additionally documented use of the tool could prove helpful in the event of a compliance audit or investigation by capturing evidence helpful to establish a culture of compliance or mitigate other potential liability concerns.
Of course app developers using these tools need to keep in mind that they are not legal advice or a substitute for legal advice. The tools only are intended to provide guidance regarding the potential likely application of the rules covered by the tool. They do not cover broad range of other federal and state Laws, regulations, rulings, and contractual commitments that also can impact the use and design of these apps and their defensibility and a broad range of circumstances. Moreover developers also should keep in mind that the use of the tools and their discussion may uncover existing or past compliance concerns, which might best be conducted within the protection of attorney-client privilege. Consequently, developers and users should consult and closely worked with experienced, qualified legal counsel to address these and other legal risks and compliance.
For Help With Comments, Investigations Or Other Needs
If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.
An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”
For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see here or contact Ms. Stamer directly.
Other Helpful Resources & Information
If you found this article of interest, you also may be interested in reviewing other Breaking News, articles and other resources available including:
- ADA May Require Employers To Accommodate Employees Testing Positive For Legally Prescribed Medications
- Selected Thoughts And Other Resources On Evolving U.S. Department Of Justice Antitrust Policy On Prescription Medical & Other Health Products Pricing & Competition; Surprise Billing; And Novel Coronavirus Planning & Response
- HR & Benefit Leadership Resilience Strategies For Leading Your People & Operations Through COVID-19 Uncertainties & Disruptions
- OSHA Nails NJ Transitional Housing Provider For Exposing Workers To COVID-19
- SEC Proposed Cybersecurity Rules Reenforce Tighten Requirements & Highlight Imperative For Market Involved & Influencing Businesses & Leaders To Clean Up Cybersecurity Practices & Disclosures
- Raise Cybersecurity & Cyberbreach Compliance & Risk Management To Defend Against Rising Cyber Regulatory & Enforcement Risks
- DOJ Civil Cyber-Fraud Initiative Pressures Federal Contractors & Grant Recipients To Tighten Cybersecurity Controls, Training & Other Safeguards
- Eased Opiate Prescription Guidelines Could Impact Employers & Health Plans
- Government Contractors Update OFCCP workplace Posters
- EEOC Sues Lilly USAA For Age Discrimination
- Per Diem Travel Reimbursement Rate Changing
- OFCCP Revises Functional Affirmative Action Program Directive
- Impact on Governmental Policy on Pricing And Access to Prescription Medical Products in the Market Place
- $1.1 Million In DOJ Penalties Show Businesses Risks Of National Origin/Citizenship Discrimination In Job Postings and Other Employment Practices
- OFCCP Extends Deadline For Contractors Objection To EEO-1 Reports FOIA Release
- 5 Ex-Methodist Hospital Employees Charged with Criminal HIPAA Violations
- Pharmacies Pay $6.8+ Million To Settle False Claims Act Civil Claims
- OCR Dental Practices Settlements Warn Providers To Honor HIPAA Access Rights
- Criminal IV Tampering Charges Against Anesthesiologist Highlight Exposures Providers And Their Facilities Can Face From Team Members Retaliatory or Other Misdeeds
- Act Promptly To Comment On ONC’s Proposed Electronic Clinical Quality Measure Draft Changes
- HIPAA Covered Entity Nailed With $300,000+ HIPAA Settlement For Improper PHI Disposal
- Protect Remote Desktop Protocols From Malware Threat
- SCOTUS: Emotional Injury Damages Not Recoverable In Patient’s Private Rehab Act and ACA Disability Discrimination Lawsuit But Other Significant Liability Risks Remain
- Justice Department Antitrust Suit Seeks To Block UnitedHealth Acquisition Of Change Healthcare As Anticompetitive
- ERISA Claims and Appeals ERISA Basics Bootcamp
- CMS Updates COVID-19 Guidance For Visiting Nursing Homes & LTC Facility Vaccination During Omicron Surge
- Justice Department COVID & Other Health Care Fraud Enforcement Thriving Despite Pandemic Emergency
- Confirm Health & Fitness App Breach & Security In Face Of New Enforcement Risks
- Biden-Harris Administration to Expand Vaccination Requirements for Health Care and Many Other Employers
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NOTICE: Terms. These materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice, a substitute for legal advice, an offer or commitment to provide legal advice or an admission. The information and statements in these materials may not address all relevant issues or apply to any situation or circumstances. The author reserves the right to qualify or retract any of these statements at any time. and does not necessarily address all relevant issues. Because the law evolves and in ways that subsequent developments could impact the currency and completeness of this discussion. The author disclaims and has no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at any time. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication. Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein. ©2022 Cynthia Marcotte Stamer. Nonexclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.