Breach filing
ArchivedSmile Design Management LLC: 10,625 individuals, Oct 2024.
Smile Design Management LLC reported a breach of unsecured protected health information to the HHS Office for Civil Rights on 7 October 2024. The filing records the organisation as a healthcare provider in Florida and lists 10,625 individuals affected, which makes it the 172nd largest of the 463 Florida filings on the register and the 333rd largest of the 741 filings submitted nationally in 2024. Among the 38 Florida filings made in 2024 it ranks 18th.
Individuals affected
10,625
As reported to HHS
Modelled cost (IBM 2025)
$1.70M
Method shown, not disclosed
Rank in FL
172nd
of 463 Florida filings
Rank in 2024
333rd
of 741 filings nationally
Section F.1 / The filing
As posted by HHS OCR
Every value below is the portal's own field for this filing, plus its rank within the register.
- Covered entity type
- Healthcare Provider
- Individuals affected
- 10,625
- Breach submission date
- 7 October 2024
- Submission year
- 2024
- Type of breach
- Hacking/IT Incident
- Location of breached information
- Network Server
- Business associate present
- No
- State
- Florida (FL)
- Portal status
- listed in the HHS OCR breach portal archive
- Rank in Florida by size
- 172nd of 463
- Rank in 2024 nationally
- 333rd of 741
- Florida median filing
- 4,912 individuals
- Register id (derived)
- FL-20241007-smile-design-management
Section F.2 / In context
Where this filing sits in Florida and in 2024
OCR classifies the incident as a hacking or IT incident, with the breached information held in a network server. Hacking/IT Incident is the type recorded on 256 of the 463 Florida filings (55%) and on 83% of all filings submitted in 2024. Network Server appears on 45% of Florida filings.
No business associate is recorded on the filing; 25% of Florida filings do involve one. At 10,625 individuals the breach is 2.2 times the Florida median filing of 4,912 and 2.7 times the national median of 4,000 across all 7,884 filings. It sits in the 10,000 to 99,999 band, which holds 1,938 filings.
As of 28 August 2026 the case is listed in the HHS OCR breach portal archive. OCR's closing summary of the case is reproduced in full below.
Florida's breach notification statute (Fla. Stat. 501.171) requires notice to affected residents within 30 days of determining a breach occurred (up to 15-day extension for good cause). Its attorney general threshold: 500 or more Florida residents. The HIPAA Breach Notification Rule ran alongside it: notice to affected individuals and to HHS without unreasonable delay and no later than 60 days after discovery, which is the clock that put this filing on the portal.
Multiplying 10,625 individuals by IBM's $160 customer-PII cost per record (Cost of a Data Breach 2025, the figure the site's calculator uses) gives a modelled $1.70M; the 2026 edition's $192 gives $2.04M. Both are modelled estimates with the method shown, not costs disclosed by Smile Design Management LLC. For scale, IBM's 2026 average cost of a healthcare breach is $6.64M, so this filing models at 0.3 times the sector average.
Section F.3 / OCR closing summary
The portal's archived description, in full
Written by the Office for Civil Rights when the case was closed and reproduced verbatim from the HHS export.
The covered entity (CE), Smile Design Management, experienced a cyberattack that compromised the protected health information (PHI) of approximately 10,625 individuals. The PHI involved included names, addresses, dates of birth, drivers' license and Social Security numbers, financial information, and treatment information. The CE notified HHS, affected individuals, the media, and posted substitute breach notice on its website. In response to the breach, the CE implemented additional administrative, technical, and security safeguards.
Section F.5 / Modelled cost
10,625 individuals through IBM's per-record figures
Modelled cost / method shown, not a disclosed cost
ModelledIBM 2025 customer PII, $160 per record
$1.70M
10,625 x $160
IBM 2026 customer PII, $192 per record
$2.04M
10,625 x $192
Method: individuals affected, as reported by Smile Design Management LLC to HHS, multiplied by IBM's customer-PII cost per record (Cost of a Data Breach 2025 Figure 6 and the 2026 edition). No cost has been disclosed by the entity for this filing; the figure is a planning estimate, not a fact about the breach. IBM's per-record figures come from mid-volume breaches and IBM cautions against applying them to breaches involving millions of records; the site's per-record page explains where the multiplication holds and where it breaks down.
Context: IBM's average cost of a healthcare breach is $6.64M in the 2026 report ($7.42M in 2025); the global average across all sectors was $4.44M in 2025.
Cost per record: method and limits / Healthcare breach cost, IBM 2026
Section F.6 / Notification clock
Florida statute and the HIPAA rule
State notification statute
Florida: Fla. Stat. 501.171
Florida Information Protection Act (FIPA)
- Notice to individuals
- Within 30 days of determining a breach occurred (up to 15-day extension for good cause)
- Attorney general threshold
- 500 or more Florida residents (Within 30 days of the breach determination)
- Private right of action
- No: FIPA does not permit direct individual lawsuits; AG enforcement only
- Penalty
- Escalating civil penalties up to $500,000 per breach; also an unfair or deceptive trade practice
The HIPAA Breach Notification Rule runs alongside the state statute: notice to affected individuals and to HHS without unreasonable delay and no later than 60 days after discovery.
Section F.7 / Peer filings
Florida filings closest in size
Neighbours by size rank among Florida filings in 2024, topped up from other years where 2024 has too few. Filings of 10,000 or more link to their own page.
| Covered entity | Type | Individuals | Submitted | Breach type | Location | BA |
|---|---|---|---|---|---|---|
| Bay Area Heart Center, PA | Healthcare Provider | 11,709 | 30 Jan 2024 | |||
| Lakeview Health Systems, LLC | Healthcare Provider | 10,772 | 29 May 2024 | |||
| Call 4 Health, Inc. | Business Associate | 10,434 | 17 May 2024 | |||
| Orlando VA Medical Center | Healthcare Provider | 9,850 | 5 Mar 2024 |
Index / Companion schedules
13 HHS breach register
→Hub: every filing, by state, year and entity.
04 Biggest breaches
→Mega-breaches with primary-source cost figures.
Industry / Healthcare
→IBM 2026: $6.64M average, 13 years at #1.
Regulation / HIPAA penalties
→OCR enforcement tiers and the 60-day rule.
11 50-state laws
→Deadline, AG threshold and penalties per state.
Cost / Per record
→Where the per-record model is reliable.
Provenance
Source: U.S. Department of Health and Human Services, Office for Civil Rights, Breach Portal (breaches affecting 500 or more individuals), retrieved 2026-08-28. Public domain. Individuals affected and dates as reported by the covered entity.
Portal: ocrportal.hhs.gov breach report. Statutory basis: HITECH Act section 13402(e)(4): the Secretary must post a list of breaches of unsecured protected health information affecting 500 or more individuals. Breaches affecting fewer than 500 individuals are reported to OCR annually and are not posted, so they are not on this register. Status wording follows the portal's two tabs ("Cases Currently Under Investigation" and "Archive") as of 28 August 2026; a filing moves to the archive when OCR closes the case. Modelled costs on this site are a method applied to the reported count, using IBM Cost of a Data Breach per-record figures, and are never a cost disclosed by the entity. This row: hhs-breach-archive__2026-08-28.csv, export row 724.
Corrections: if you represent a listed entity and the portal row has been amended, email [email protected] with the portal entry and we will re-pull the export.